BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 1654185 · Received April 8, 2010

    Report

    Report Number
    2939204-2010-00631
    Event Type
    Malfunction
    Date Received
    April 8, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED GUIDEWIRE NOTED THE DEVICE WAS KINKED AT 121.2CM AND WAVY AT APPROXIMATELY 274.0CM TO 277CM FROM ITS PROXIMAL END, THIS MOST LIKELY OCCURRED DUE TO HANDLING OF THE DEVICE DURING THE PROCEDURE. THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELED ON SEVERAL PLACES ALONG ITS PROXIMAL SECTION BETWEEN 121.0CM TO 122.5CM.THE TORQUE DEVICE BRASS COLLETT MARKINGS APPEARED TO BE ON THE GUIDEWIRE. FROM THE CONDITION OF THE GUIDEWIRE IT APPEARED THAT THE TORQUE DEVICE HAD BEEN DRAGGED DOWN THE DEVICE. THE COATING DAMAGE ON THE PROXIMAL END OF THE DEVICE WAS MOST PROBABLY DUE TO THE INSUFFICIENT TIGHTENING OF THE TORQUE DEVICE. THE DISTAL END OF THE GUIDEWIRE WAS SHAPED. THE LABELING STATES: ¿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.).¿ THEREFORE, IT WAS DETERMINED THAT USER ERROR CONTRIBUTED TO THE PEELING FOUND ON THE PROXIMAL END OF THE GUIDEWIRE.

    Additional Manufacturer Narrative · 1

    PMA / 510 (K) #: K032146, K002907.

    Description of Event or Problem · 1

    THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED BACK TO BOSTON SCIENTIFIC. OBSERVATION OF THE DEVICE FOUND THE POLYTETRAFLUOROETHYLENE (PTFE) COATING TO BE PEELED AND THE GUIDEWIRE TO BE KINKED. TO THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED BACK TO BOSTON SCIENTIFIC. OBSERVATION OF THE DEVICE FOUND THE POLYTETRAFLUOROETHYLENE (PTFE) COATING TO BE PEELED AND THE GUIDEWIRE TO BE KINKED. TO THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY UNK174

    Patients

    Seq Age Sex Outcome Treatment
    1 (B) (4) - F/G WINGSPAN STENT SYSTEM