BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 1517778 · Received October 16, 2009

    Report

    Report Number
    2939204-2009-00782
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Report Date
    September 23, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: UNK AS THE BATCH/LOT # WAS NOT DISCLOSED. ADDITIONAL PMA/510(K): K023700, K002907, K053268. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED OF, BY THE FACILITY. THE DIRECTIONS FOR USE (DFU) RECOMMENDS THAT THE PHYSICIAN "SECURELY FASTEN THE TORQUE DEVICE ONTO THE WIRE TO PREVENT SLIPPAGE OF THE TORQUE DEVICE AND TO AVOID PRODUCT DAMAGE (I.E., CORE WIRE ABRASION/PEELING OF PTFE, ETC.)" IT WAS CONFIRMED BY THE FACILITY THAT THE TORQUE DEVICE WAS FASTENED DOWN AS INSTRUCTED IN THE DFU. ALL INSTRUCTIONS APPEAR TO HAVE BEEN FOLLOWED AS INSTRUCTED. BASED ON THE INVESTIGATION RESULTS AND THE INFORMATION OBTAINED, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN NOTED THE COATING ON THE PROXIMAL PORTION OF THE GUIDEWIRE HAD BEEN DAMAGED "AS IF THE COATING WAS WORN DUE TO FRICTION CAUSED BY HANDLING OF THE TORQUE DEVICE". THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO GUIDEWIRE DQX BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1