BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP

    MDR report key: 22287408 · Received June 18, 2025

    Report

    Report Number
    2124215-2025-39287
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 23, 2025
    Report Date
    June 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729469643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO RELEASE STONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ZERO TIP BASKET WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, THE BASKET WAS STUCK IN THE ACCESS SHEATH WITH STONE IN IT, AND THE BASKET WIRE BROKE UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911562 ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063901050 0035935699 08714729469643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown