BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROSTOMY SHEATHS AND DILATORS

    MDR report key: 22154967 · Received June 5, 2025

    Report

    Report Number
    2124215-2025-36922
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    January 1, 2012
    Report Date
    June 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GCC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE OF EVENT IS UNKNOWN; THEREFORE, FIRST DAY OF TREATMENT MONTH/YEAR HAS BEEN SELECTED. BLOCK D4, H4: 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 PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. BLOCK G2: LITERATURE SOURCE: KARSH, O. (2023). DOES PREVIOUS OPEN NEPHROLITHOTOMY OR FAILED EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY THERAPY AFFECT PERCUTANEOUS NEPHROLITHOTOMY PERFORMANCE AND OUTCOME: J UROL SURG, 2023;10(3):266-271, HTTPS://DOI/10.4274/JUS.GALENOS.2023.2023-7-7. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E230101 CAPTURES THE REPORTABLE EVENT OF FEVER. IMDRF PATIENT CODE E1310 CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. IMDRF PATIENT CODE E0505 CAPTURES THE REPORTABLE EVENT OF HEMATOMA. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE/BLOOD LOSS/BLEEDING. IMDRF PATIENT CODE E0734 CAPTURES THE REPORTABLE EVENT OF PNEUMOTHORAX. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F2302 CAPTURES THE REPORTABLE EVENT OF BLOOD TRANSFUSION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF GENERAL UROLOGY. THE STUDY AIMED TO SUMMARIZE THE EXPERIENCE WITH PATIENTS UNDERGOING PERCUTANEOUS NEPHROLITHOTOMY (PNL) WITH A PREVIOUS HISTORY OF EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) TREATMENT OR OPEN NEPHROLITHOTOMY AND COMPARE THEM WITH PATIENTS WHO UNDERWENT PNL ALONE. A TOTAL OF 403 PATIENTS RECEIVED PNL BETWEEN 2012 AND 2022. A PERCUTANEOUS ACCESS NEEDLE WAS USED AS IT WAS INTRODUCED INTO THE CALYX SYSTEM OF THE KIDNEY. FLUOROSCOPY WAS USED TO PLACE A ZEBRA NITINOL GUIDEWIRE IN THE COLLECTING SYSTEM. ALSO, AN AMPLATZ DILATOR WAS USED TO DILATE THE TRACT. UPON PROCEDURES, IT WAS REVEALED THAT FEVER WAS EXPERIENCED BY 14 PATIENTS, MEANWHILE URINARY TRACT INFECTION WAS OBSERVED IN 9 PATIENTS WITH ANTIBIOTIC TREATMENT. ADDITIONALLY, 29 PATIENTS REQUIRED BLOOD TRANSFUSION. URETERORENOSCOPY WAS PERFORMED FOR 10 PATIENTS DUE TO STONE MIGRATION INTO THE URETER. DOUBLE-J STENT INSERTION WAS PERFORMED IN 7 PATIENTS BECAUSE OF PROLONGED URINARY LEAK AFTER NEPHROSTOMY CATHETER REMOVAL. SELECTIVE ANGIOEMBOLIZATION WAS PERFORMED FOR 2 PATIENTS DUE TO UNCONTROLLED BLEEDING. COLON PERFORATION OCCURRED IN 2 PATIENTS AND THEY WERE FOLLOWED UP WITH TUBE COLOSTOMY AND DISCHARGED WITHOUT ANY ISSUES. ONE PATIENT EXPERIENCED CONTINUED BLEEDING AND HEMATOMA IN THE POSTOPERATIVE FOLLOW-UP, LEADING TO NEPHRECTOMY, WHEREAS 2 PATIENTS DEVELOPED PNEUMOTHORAX AND REQUIRED CHEST TUBE INSERTION AFTER DISCHARGE WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619481 NEPHROSTOMY SHEATHS AND DILATORS DILATOR, CATHETER GCC BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| O