BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP

    MDR report key: 19974971 · Received August 13, 2024

    Report

    Report Number
    2124215-2024-48202
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729469643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO 07/01/2024 BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF PULL WIRE BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, THE BASKET WAS NOT WORKING AFTER A FEW TRIES. REPORTEDLY, IT WAS FOUND THAT THE PULL WIRE AND BASKET WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619209 ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063901050 0033283135 08714729469643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown