BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE¿

    MDR report key: 22685991 · Received August 1, 2025

    Report

    Report Number
    22685991
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    May 22, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC FARADRIVE STEERABLE SHEATH COLLAR BROKE WHILE MAPPING. LOT CL13825 EXP 03-21-2027 REF M004PF21M402. NO INJURY OR HARM OCCURRED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165163 FARADRIVE¿ CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION M004PF21M402 CL13825

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male