BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP

    MDR report key: 20051132 · Received August 23, 2024

    Report

    Report Number
    2124215-2024-51472
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729469643
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BASKET DETACHED. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF THE UNEXPECTED MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ZERO TIP BASKET WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE STONE GOT STUCK IN THE BASKET AND THE BASKET WAS DISENGAGED IN THE PATIENT. THE BASKET WAS RETRIEVED FROM THE KIDNEY USING A GRASPER. 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
    1363471 ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063901050 0033783381 08714729469643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention