BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP

    MDR report key: 20067648 · Received August 26, 2024

    Report

    Report Number
    2124215-2024-52989
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    January 1, 2023
    Report Date
    November 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729469643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE PROVIDED EVENT DATE OF MARCH 2, 2024, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE ARTICLE WAS PUBLISHED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE: WANG, L., ZHOU, Z., GAO, P., YANG, Y., DING, Q., WU, Z. (2024). COMPARISON OF TRADITIONAL AND SUCTIONING URETERAL ACCESS SHEATH DURING RETROGRADE INTRARENAL SURGERY IN THE TREATMENT OF RENAL CALCULI. LANGENBECK'S ARCHIVES OF SURGERY (2024) 409:81, DOI: HTTPS://DOI.ORG/10.1007/S00423-024-03275-2 BLOCK H6: IMDRF E230101 CAPTURES THE REPORTABLE EVENT OF FEVER. IMDRF E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF E1302 CAPTURES THE REPORTABLE EVENT OF HEMATURIA. IMDRF E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY/ILLNESS/IMPAIRMENT.

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO JANUARY 1, 2023 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE EVENT YEAR OF 2023. BLOCK G2: LITERATURE: WANG, L., ZHOU, Z., GAO, P., YANG, Y., DING, Q., WU, Z. (2024). COMPARISON OF TRADITIONAL AND SUCTIONING URETERAL ACCESS SHEATH DURING RETROGRADE INTRARENAL SURGERY IN THE TREATMENT OF RENAL CALCULI. LANGENBECK'S ARCHIVES OF SURGERY (2024) 409:81, DOI: HTTPS://DOI.ORG/10.1007/S00423-024-03275-2. BLOCK H6: IMDRF E230101 CAPTURES THE REPORTABLE EVENT OF FEVER. IMDRF E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF E1302 CAPTURES THE REPORTABLE EVENT OF HEMATURIA. IMDRF E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY/ILLNESS/IMPAIRMENT. BLOCK H11: ADDITIONAL INFORMATION. UPDATED FIELD BLOCK B3: DATE OF EVENT. UPDATED FIELD BLOCK D4: BLOCK D4: MODEL NUMBER, LOT NUMBER, EXPIRATION DATE, AND UNIQUE IDENTIFIER (UDI) #.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF LANGENBECK'S ARCHIVES OF SURGERY THAT A STUDY WAS CONDUCTED TO COMPARE THE EFFICIENCY AND CLINICAL OUTCOMES BETWEEN THE SUCTIONING URETERAL ACCESS SHEATH (UAS) GROUP AND THE TRADITIONAL UAS GROUP DURING RETROGRADE INTRARENAL SURGERY (RIRS) FOR KIDNEY STONES AND EXPLORE THE IMPACT OF SUCTIONING UAS ON POSTOPERATIVE INFECTIOUS COMPLICATIONS. CLINICAL DATA INCLUDED THE INFORMATION OF 162 PATIENTS WITH KIDNEY STONES WHO UNDERWENT RIRS WITH A TRADITIONAL UAS OR A SUCTIONING UAS BETWEEN MARCH 2021 AND MAY 2023. FOR THE PROCEDURE'S TECHNIQUE, A ZERO TIP BASKET WAS USED TO RELOCATE LOWER POLE STONES OR RETRIEVE STONE FRAGMENTS WHEN NECESSARY. WITHIN THE COMPLICATIONS, IT WAS FOUND THAT THE PATIENTS IN THE TRADITIONAL UAS GROUP EXPERIENCED A SIGNIFICANTLY HIGHER INCIDENCE OF UROSEPSIS (10.81%) THAN THE SUCTIONING UAS GROUP (2.82%). SEPTIC SHOCK WAS ALSO LISTED IN THE COMPLICATIONS; HOWEVER, WITH NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS. ADDITIONALLY, THE INCIDENCE OF FEVER WAS SIGNIFICANTLY HIGHER IN THE TRADITIONAL UAS GROUP THAN THE SUCTIONING UAS GROUP (16.90% AND 7.04% RESPECTIVELY). LASTLY, COMPLICATIONS LIKE HEMATURIA AND PERFORATION WERE PRESENT, BUT WITH NO SIGNIFICANT DIFFERENCE WITHIN THE GROUPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF LANGENBECK'S ARCHIVES OF SURGERY THAT A STUDY WAS CONDUCTED TO COMPARE THE EFFICIENCY AND CLINICAL OUTCOMES BETWEEN THE SUCTIONING URETERAL ACCESS SHEATH (UAS) GROUP AND THE TRADITIONAL UAS GROUP DURING RETROGRADE INTRARENAL SURGERY (RIRS) FOR KIDNEY STONES AND EXPLORE THE IMPACT OF SUCTIONING UAS ON POSTOPERATIVE INFECTIOUS COMPLICATIONS. CLINICAL DATA INCLUDED THE INFORMATION OF 162 PATIENTS WITH KIDNEY STONES WHO UNDERWENT RIRS WITH A TRADITIONAL UAS OR A SUCTIONING UAS BETWEEN MARCH 2021 AND MAY 2023. FOR THE PROCEDURE'S TECHNIQUE, A ZERO TIP BASKET WAS USED TO RELOCATE LOWER POLE STONES OR RETRIEVE STONE FRAGMENTS WHEN NECESSARY. WITHIN THE COMPLICATIONS, IT WAS FOUND THAT THE PATIENTS IN THE TRADITIONAL UAS GROUP EXPERIENCED A SIGNIFICANTLY HIGHER INCIDENCE OF UROSEPSIS (10.81%) THAN THE SUCTIONING UAS GROUP (2.82%). SEPTIC SHOCK WAS ALSO LISTED IN THE COMPLICATIONS; HOWEVER, WITH NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS. ADDITIONALLY THE INCIDENCE OF FEVER WAS SIGNIFICANTLY HIGHER IN THE TRADITIONAL UAS GROUP THAN THE SUCTIONING UAS GROUP (16.90% AND 7.04% RESPECTIVELY). LASTLY, COMPLICATIONS LIKE HEMATURIA AND PERFORATION WERE PRESENT, BUT WITH NO SIGNIFICANT DIFFERENCE WITHIN THE GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269810 ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063901050 0028368183 08714729469643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other