BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2 GUIDEWIRE

    MDR report key: 1513455 · Received October 9, 2009

    Report

    Report Number
    2939204-2009-00773
    Event Type
    Malfunction
    Date Received
    October 9, 2009
    Report Date
    September 10, 2009
    Manufacturer
    BOSTON SCIENTIFIC WEST VALLEY CITY
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE. UNK. VISUAL INSPECTION OF THE DEVICE REVEALED A KINK 124.0 CM FROM THE PROXIMAL END. IN A REGION BETWEEN 120CM AND 126CM THERE WERE AREAS WHERE THE PTFE COATING WAS MISSING OR PARTIALLY PEELED UP FROM THE STAINLESS STEEL CORE WIRE. IN THIS REGION THERE WERE MARKINGS FROM THE TORQUE DEVICE BRASS COLLETT MARKINGS THAT ARE INDICATIVE THAT THE TORQUE DEVICE HAD BEEN DRAGGED DOWN THE DEVICE. THE DIRECTIONS FOR USE STATE "SECURELY FASTEN THE TORQUE DEVICE INTO THE WIRE TO PREVENT SLIPPAGE OF THE TORQUE DEVICE AND TO AVOID PRODUCT DAMAGE (I.E., CORE WIRE ABRASION/PEELING IF PTFE, ETC.) IT IS EVIDENT BY THE DAMAGE TO THE PTFE COATING THAT THE TORQUE DEVICE WAS NOT FASTENED DOWN PROPERLY SO IT WAS CONCLUDED THAT THE MOST PROBABLE CAUSE OF THIS COATING DAMAGE WAS USER ERROR. THE DEVICE WAS NOTED TO BE SLIGHTLY WAVY ON THE DISTAL SECTION AND THE CORE WIRE WAS OBSERVED THROUGH THE DISTAL TIP DOME. THE NITINOL TUBING WAS REMOVED IN THE LAB TO REVEAL THAT DISTAL TIP OF THE CORE WIRE HAD SEPARATED. THE NITINOL TUBING PROXIMAL AND DISTAL BONDS WERE CONFIRMED TO BE INTACT. SCANNING ELECTRON MICROSCOPY (SEM) REVEALED THE CORE WIRE SURFACE HAD A ROUGHENED/PITTED APPEARANCE. FROM THE SEM ANALYSIS THERE WAS NO INDICATION THAT THE MFG PROCESS CAUSED OR CONTRIBUTED TO THE OBSERVED ANOMALIES IN THE CORE WIRE SURFACE. THE SEM ANALYSIS DID NOT REVEAL ANY INDICATION OF TORSIONAL STRESS SO IT DOES NOT APPEAR THAT THE CORE WIRE DISTAL TIP SEPARATION WAS DUE TO TORSIONAL OVERLOAD. THE POSSIBLE CAUSE OF THE CORE WIRE DISTAL TIP SEPARATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THE POLYTETRAFLUOROETHYLENE (PTFE) COATING TO BE MISSING ON THE PROXIMAL END OF THE DEVICE AND THE DISTAL TIP OF THE CORE WIRE WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2 GUIDEWIRE DQX BOSTON SCIENTIFIC WEST VALLEY CITY M00326510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1