BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MALECOT NEPHROSTOMY CATHETERS

    MDR report key: 22069572 · Received May 22, 2025

    Report

    Report Number
    2124215-2025-31989
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Report Date
    July 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TIMEFRAME OF EVENT DATA: EVENTS FROM LITHOTRIPSY PROCEDURES PERFORMED FROM JANUARY 2015 TO OCTOBER 2024 SUMMARY OF EVENTS: FOLLOWING PROCEDURES INVOLVING MALECOT NEPHROSTOMY CTHETER SETS, 10 PATIENTS EXPERIENCED CATHETER DISLODGEMENT AND 2 MORE EXPERIENCED CATHETER OBSTRUCTION. TOTAL NUMBER OF PATIENTS: 770. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. AS THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. CONTEXTUAL ANALYSIS OF STUDY DATA: CATHETER DISLODGEMENT: THE RATES OF CATHETER DISLODGEMENT IN THE STATE-OF-THE-ART REVIEW, INCLUDING SIMILAR DEVICE LITERATURE, WERE REPORTED FROM 2.6%-33.3%.6-8 THEREFORE, THE RATE OF 1.3% IS IN LINE WITH THE STATE-OF-THE-ART CATHETER DISLODGEMENT RATES. CATHETER OBSTRUCTION: CATHETER OBSTRUCTION RATES FROM THE STATE-OF-THE-ART REVIEW INCLUDING SIMILAR DEVICE LITERATURE WERE REPORTED FROM 1.4%-29.2% WHICH ALIGNS TO THE RATE IN THIS STUDY OF 0.3%.8-10 THERE WERE NO UNEXPECTED ADVERSE EVENTS IN THIS STUDY. 1. PABON-RAMOS WM, DARIUSHNIA SR, WALKER TG, ET AL. QUALITY IMPROVEMENT GUIDELINES FOR PERCUTANEOUS NEPHROSTOMY. J VASC INTERV RADIOL. MAR 2016;27(3):410-4. DOI:10.1016/J.JVIR.2015.11.045. 2. DENG J, LI J, WANG L, ET AL. STANDARD VERSUS MINI-PERCUTANEOUS NEPHROLITHOTOMY FOR RENAL STONES: A META-ANALYSIS. SCAND J SURG. SEP 2021;110(3):301-311. DOI:10.1177/1457496920920474 3. WAN C, WANG D, XIANG J, ET AL. COMPARISON OF POSTOPERATIVE OUTCOMES OF MINI PERCUTANEOUS NEPHROLITHOTOMY AND STANDARD PERCUTANEOUS NEPHROLITHOTOMY: A META-ANALYSIS. UROLITHIASIS. OCT 2022;50(5):523-533. DOI:10.1007/S00240-022-01349-8. 4. JIAO B, LUO Z, HUANG T, ZHANG G, YU J. A SYSTEMATIC REVIEW AND META-ANALYSIS OF MINIMALLY INVASIVE VS. STANDARD PERCUTANEOUS NEPHROLITHOTOMY IN THE SURGICAL MANAGEMENT OF RENAL STONES. EXP THER MED. MAR 2021;21(3):213. 5. CHEN Y, WEN Y, YU Q, DUAN X, WU W, ZENG G. PERCUTANEOUS NEPHROLITHOTOMY VERSUS FLEXIBLE URETEROSCOPIC LITHOTRIPSY IN THE TREATMENT OF UPPER URINARY TRACT STONES: A META-ANALYSIS COMPARING CLINICAL EFFICACY AND SAFETY. BMC UROL. JUL 25 2020;20(1):109. 6. GAUHAR V, PIROLA GM, SCARCELLA S, ET AL. NEPHROSTOMY TUBE VERSUS DOUBLE J URETERAL STENT IN PATIENTS WITH MALIGNANT URETERIC OBSTRUCTION. A SYSTEMATIC REVIEW AND META-ANALYSIS OF COMPARATIVE STUDIES. INT BRAZ J UROL. NOV-DEC 2022;48(6):903-914. 7. ZHANG B, LI L, ZHANG G, WANG J, CAO B, LI Z. APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS NEPHROSTOMY IN THE TREATMENT OF A SOLITARY KIDNEY WITH HYDRONEPHROSIS DUE TO RENAL TUBERCULOSIS. ABDOM RADIOL (NY). FEB 2024;49(2):535-541. 8. FARHAN A, LYONS GR. CLINICAL OUTCOMES FOLLOWING PERCUTANEOUS URINARY DIVERSION FOR HEMORRHAGIC CYSTITIS. J VASC INTERV RADIOL. JUL 2022;33(7):841-844. 9. NAS OF, OZTEPE M, CANDAN S, ET AL. PERCUTANEOUS NEPHROSTOMY EXPERIENCE IN PEDIATRIC PATIENTS: COMPARISON OF FINE AND THICK NEEDLE TECHNIQUES. THE EUROPEAN RESEARCH JOURNAL. 1 2023;9(3):511-516. 10. STEWART JK, SMITH TP, KIM CY. CLINICAL IMPLICATIONS OF ACUTE PELVICALICEAL HEMATOMA FORMATION DURING PERCUTANEOUS CATHETER NEPHROSTOMY INSERTION. CLIN IMAGING. MAY - JUN 2017;43:180-183. RACE: AMERICAN INDIAN OR ALASKAN NATIVE 0.1%, ASIAN 8.4%, BLACK OR AFRICAN AMERICAN 10.0%, OTHER RACE 12.6%, UNKNOWN 3.5%, AND WHITE 65.3%. ETHNICITY: NOT HISPANIC OR LATINO 82.3%, HISPANIC OR LATINO 10.8%, AND UNKNOWN 6.9%.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G2: REPORT SOURCE. TIMEFRAME OF EVENT DATA: EVENTS FROM LITHOTRIPSY PROCEDURES PERFORMED FROM JANUARY 2015 TO OCTOBER 2024 SUMMARY OF EVENTS: FOLLOWING PROCEDURES INVOLVING MALECOT NEPHROSTOMY CTHETER SETS, 10 PATIENTS EXPERIENCED CATHETER DISLODGEMENT AND 2 MORE EXPERIENCED CATHETER OBSTRUCTION. TOTAL NUMBER OF PATIENTS: 770 DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. AS THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. CONTEXTUAL ANALYSIS OF STUDY DATA: CATHETER DISLODGEMENT THE RATES OF CATHETER DISLODGEMENT IN THE STATE-OF-THE-ART REVIEW, INCLUDING SIMILAR DEVICE LITERATURE, WERE REPORTED FROM 2.6%-33.3%.6-8 THEREFORE, THE RATE OF 1.3% IS IN LINE WITH THE STATE-OF-THE-ART CATHETER DISLODGEMENT RATES. CATHETER OBSTRUCTION CATHETER OBSTRUCTION RATES FROM THE STATE-OF-THE-ART REVIEW INCLUDING SIMILAR DEVICE LITERATURE WERE REPORTED FROM 1.4%-29.2% WHICH ALIGNS TO THE RATE IN THIS STUDY OF 0.3%.8-10 THERE WERE NO UNEXPECTED ADVERSE EVENTS IN THIS STUDY. 1. PABON-RAMOS WM, DARIUSHNIA SR, WALKER TG, ET AL. QUALITY IMPROVEMENT GUIDELINES FOR PERCUTANEOUS NEPHROSTOMY. J VASC INTERV RADIOL. MAR 2016;27(3):410-4. DOI:10.1016/J.JVIR.2015.11.045 2. DENG J, LI J, WANG L, ET AL. STANDARD VERSUS MINI-PERCUTANEOUS NEPHROLITHOTOMY FOR RENAL STONES: A META-ANALYSIS. SCAND J SURG. SEP 2021;110(3):301-311. DOI:10.1177/1457496920920474 3. WAN C, WANG D, XIANG J, ET AL. COMPARISON OF POSTOPERATIVE OUTCOMES OF MINI PERCUTANEOUS NEPHROLITHOTOMY AND STANDARD PERCUTANEOUS NEPHROLITHOTOMY: A META-ANALYSIS. UROLITHIASIS. OCT 2022;50(5):523-533. DOI:10.1007/S00240-022-01349-8 4. JIAO B, LUO Z, HUANG T, ZHANG G, YU J. A SYSTEMATIC REVIEW AND META-ANALYSIS OF MINIMALLY INVASIVE VS. STANDARD PERCUTANEOUS NEPHROLITHOTOMY IN THE SURGICAL MANAGEMENT OF RENAL STONES. EXP THER MED. MAR 2021;21(3):213. 5. CHEN Y, WEN Y, YU Q, DUAN X, WU W, ZENG G. PERCUTANEOUS NEPHROLITHOTOMY VERSUS FLEXIBLE URETEROSCOPIC LITHOTRIPSY IN THE TREATMENT OF UPPER URINARY TRACT STONES: A META-ANALYSIS COMPARING CLINICAL EFFICACY AND SAFETY. BMC UROL. JUL 25 2020;20(1):109. 6. GAUHAR V, PIROLA GM, SCARCELLA S, ET AL. NEPHROSTOMY TUBE VERSUS DOUBLE J URETERAL STENT IN PATIENTS WITH MALIGNANT URETERIC OBSTRUCTION. A SYSTEMATIC REVIEW AND META-ANALYSIS OF COMPARATIVE STUDIES. INT BRAZ J UROL. NOV-DEC 2022;48(6):903-914. 7. ZHANG B, LI L, ZHANG G, WANG J, CAO B, LI Z. APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS NEPHROSTOMY IN THE TREATMENT OF A SOLITARY KIDNEY WITH HYDRONEPHROSIS DUE TO RENAL TUBERCULOSIS. ABDOM RADIOL (NY). FEB 2024;49(2):535-541. 8. FARHAN A, LYONS GR. CLINICAL OUTCOMES FOLLOWING PERCUTANEOUS URINARY DIVERSION FOR HEMORRHAGIC CYSTITIS. J VASC INTERV RADIOL. JUL 2022;33(7):841-844. 9. NAS OF, OZTEPE M, CANDAN S, ET AL. PERCUTANEOUS NEPHROSTOMY EXPERIENCE IN PEDIATRIC PATIENTS: COMPARISON OF FINE AND THICK NEEDLE TECHNIQUES. THE EUROPEAN RESEARCH JOURNAL. 1 2023;9(3):511-516. 10. STEWART JK, SMITH TP, KIM CY. CLINICAL IMPLICATIONS OF ACUTE PELVICALICEAL HEMATOMA FORMATION DURING PERCUTANEOUS CATHETER NEPHROSTOMY INSERTION. CLIN IMAGING. MAY - JUN 2017;43:180-183. RACE: AMERICAN INDIAN OR ALASKAN NATIVE 0.1%, ASIAN 8.4%, BLACK OR AFRICAN AMERICAN 10.0%, OTHER RACE 12.6%, UNKNOWN 3.5%, AND WHITE 65.3%. ETHNICITY: NOT HISPANIC OR LATINO 82.3%, HISPANIC OR LATINO 10.8%, AND UNKNOWN 6.9%. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 10 REPORTED INCIDENTS FOR CATHETER DISLODGEMENT AND 2 OF CATHETER OBSTRUCTION. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: MALECOT NEPHROSTOMY CATHETER INSERTION OR RE-ENTRY IN ONE OF THE FOLLOWING PROCEDURES: ANTEGRADE PYELOGRAPHY, PRESSURE/PERFUSION STUDY (WHITAKER TEST), NEPHROSTOMY CATHETER DRAINAGE, PERFUSION CHEMOLYSIS OF RENAL STONES, POST-PERCUTANEOUS NEPHROLITHOTOMY AND POST-PERCUTANEOUS RESECTION AND COAGULATION OF UROTHELIAL TUMORS. AGE: AVERAGE AGE OF 59.1 YEARS. SEX: FEMALE: 51.0% / MALE: 48.6% / UNKNOWN: 0.4%. BOSTON SCIENTIFIC PERFORMED A RETROSPECTIVE REVIEW OF THE BOSTON SCIENTIFIC MALECOT / RE-ENTRY MALECOT NEPHROSTOMY CATHETER SETS IN THE TRUVETA DATABASE. THIS ANALYSIS AIMED TO EVALUATE THE RATES OF OCCURRENCE OF SAFETY ENDPOINTS IN THE REAL-WORLD USE OF THE BSC MALECOT DEVICES. THE PROCEDURES WERE PERFORMED FROM JANUARY 2015 TO OCTOBER 2024. WITHIN THIS ANALYSIS, A TOTAL OF 770 PATIENTS UNDERWENT MALECOT NEPHROSTOMY CATHETER INSERTION O RE-ENTRY. FOLLOWING THE PROCEDURES, 10 PATIENTS EXPERIENCED CATHETER DISLODGEMENT AND 2 MORE EXPERIENCED CATHETER OBSTRUCTION. PATIENT EVENTS WERE IDENTIFIED AS EVENT TERMS WITH RATES. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. DATA OBTAINED FROM TRUVETA FOR THIS STUDY IS DE-IDENTIFIED BEFORE BEING ACCESSED BY BOSTON SCIENTIFIC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO OUR ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE STUDY DATA DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.

    Description of Event or Problem · 0

    Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;19771538,,,2/25/2025,MALECOT NEPHROSTOMY CATHETERS,"catheter, nephrostomy, general & plastic surgery",UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,UNK-P-MALECOT_NEPHROSTOMY_CATHETERS,,,K820867,2/25/2025,MA,"This report summarizes 10 reported incidents for catheter dislodgement and 2 of catheter obstruction. Device relationship to the events reported is not provided. ;;Type of Procedure: Malecot Nephrostomy Catheter insertion or re-entry in one of the following procedures: Antegrade pyelography, Pressure/Perfusion study (Whitaker test), Nephrostomy Catheter drainage, Perfusion chemolysis of renal stones, Post-percutaneous nephrolithotomy and Post-percutaneous resection and coagulation of urothelial tumors. ;;Boston Scientific performed a retrospective review of the Boston Scientific Malecot / Re-Entry Malecot Nephrostomy Catheter Sets in the Truveta database. This analysis aimed to evaluate the rates of occurrence of safety endpoints in the real-world use of the BSC Malecot Devices. The procedures were performed from January 2015 to October 2024. Within this analysis, a total of 770 patients underwent Malecot Nephrostomy Catheter insertion o re-entry. Following the procedures, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: American Indian or Alaskan Native 0.1%, Asian 8.4%, Black or African American 10.0%, Other Race 12.6%, Unknown 3.5%, and White 65.3%.;Ethnicity: Not Hispanic or Latino 82.3%, Hispanic or Latino 10.8%, and Unknown 6.9%.","Timeframe of Event Data: Events from lithotripsy procedures performed from January 2015 to October 2024;;Summary of Events: Following procedures involving Malecot Nephrostomy Ctheter Sets, 10 patients experienced catheter dislodgement and 2 more experienced catheter obstruction.;Total Number of Patients: 770;;Contextual Analysis of Study Data:;Catheter Dislodgement;The rates of catheter dislodgement in the state-of-the-art review, including similar device literature, were reported from 2.6%-33.3%.6-8 Therefore, the rate of 1.3% is in line with the state-of-the-art catheter dislodgement rates. ;;Catheter Obstruction;Catheter obstruction rates from the state-of-the-art review including similar device literature were reported from 1.4%-29.2% which aligns to the rate in this study of 0.3%.8-10;;There were no unexpected adverse events in this study.;;1. Pabon-Ramos WM, Dariushnia SR, Walker TG, et al. Quality Improvement Guidelines for Percutaneous Nephrostomy. J Vasc Interv Radiol. Mar 2016;27(3):410-4. doi:10.1016/j.jvir.2015.11.045;2. Deng J, Li J, Wang L, et al. Standard versus mini-percutaneous nephrolithotomy for renal stones: a meta-analysis. Scand J Surg. Sep 2021;110(3):301-311. doi:10.1177/1457496920920474;3. Wan C, Wang D, Xiang J, et al. Comparison of postoperative outcomes of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. Oct 2022;50(5):523-533. doi:10.1007/s00240-022-01349-8;4. Jiao B, Luo Z, Huang T, Zhang G, Yu J. A systematic review and meta-analysis of minimally invasive vs. standard percutaneous nephrolithotomy in the surgical management of renal stones. Exp Ther Med. Mar 2021;21(3):213. ;5. Chen Y, Wen Y, Yu Q, Duan X, Wu W, Zeng G. Percutaneous nephrolithotomy versus flexible ureteroscopic lithotripsy in the treatment of upper urinary tract stones: a meta-analysis comparing clinical efficacy and safety. BMC Urol. Jul 25 2020;20(1):109. ;6. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;7. Zhang B, Li L, Zhang G, Wang J, Cao B, Li Z. Application of ultrasound-guided percutaneous nephrostomy in the treatment of a solitary kidney with hydronephrosis due to renal tuberculosis. Abdom Radiol (NY). Feb 2024;49(2):535-541. ;8. Farhan A, Lyons GR. Clinical Outcomes following Percutaneous Urinary Diversion for Hemorrhagic Cystitis. J Vasc Interv Radiol. Jul 2022;33(7):841-844. ;9. Nas OF, Oztepe M, Candan S, et al. Percutaneous nephrostomy experience in pediatric patients: comparison of fine and thick needle techniques. The European Research Journal. 1 2023;9(3):511-516. ;10. Stewart JK, Smith TP, Kim CY. Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion. Clin Imaging. May - Jun 2017;43:180-183. ;",,Average 59.1 years,"Female: 51.0%; Male: 48.6%; Unknown: 0.4%;",,,,E2403,F26,A051201; A1409,G07001,B17,C19,D15,No,0;

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 10 REPORTED INCIDENTS FOR CATHETER DISLODGEMENT AND 2 OF CATHETER OBSTRUCTION. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: MALECOT NEPHROSTOMY CATHETER INSERTION OR RE-ENTRY IN ONE OF THE FOLLOWING PROCEDURES: ANTEGRADE PYELOGRAPHY, PRESSURE/PERFUSION STUDY (WHITAKER TEST), NEPHROSTOMY CATHETER DRAINAGE, PERFUSION CHEMOLYSIS OF RENAL STONES, POST-PERCUTANEOUS NEPHROLITHOTOMY AND POST-PERCUTANEOUS RESECTION AND COAGULATION OF UROTHELIAL TUMORS. AGE: AVERAGE AGE OF 59.1 YEARS SEX: FEMALE: 51.0% / MALE: 48.6% / UNKNOWN: 0.4%. BOSTON SCIENTIFIC PERFORMED A RETROSPECTIVE REVIEW OF THE BOSTON SCIENTIFIC MALECOT / RE-ENTRY MALECOT NEPHROSTOMY CATHETER SETS IN THE TRUVETA DATABASE. THIS ANALYSIS AIMED TO EVALUATE THE RATES OF OCCURRENCE OF SAFETY ENDPOINTS IN THE REAL-WORLD USE OF THE BSC MALECOT DEVICES. THE PROCEDURES WERE PERFORMED FROM JANUARY 2015 TO OCTOBER 2024. WITHIN THIS ANALYSIS, A TOTAL OF 770 PATIENTS UNDERWENT MALECOT NEPHROSTOMY CATHETER INSERTION O RE-ENTRY. FOLLOWING THE PROCEDURES, 10 PATIENTS EXPERIENCED CATHETER DISLODGEMENT AND 2 MORE EXPERIENCED CATHETER OBSTRUCTION. PATIENT EVENTS WERE IDENTIFIED AS EVENT TERMS WITH RATES. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. DATA OBTAINED FROM TRUVETA FOR THIS STUDY IS DE-IDENTIFIED BEFORE BEING ACCESSED BY BOSTON SCIENTIFIC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO OUR ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE STUDY DATA DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261392 MALECOT NEPHROSTOMY CATHETERS CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown