BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVS 2000 SYNCHRO2 GUIDEWIRE

    MDR report key: 1961573 · Received January 14, 2011

    Report

    Report Number
    2939204-2011-00017
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    October 26, 2010
    Report Date
    January 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A BEND WAS NOTED TO THE DISTAL SECTION OF THE DEVICE. THE PROXIMAL GLUE FILLET WAS MISSING FROM THE NITINOL TUBING AND THE STAINLESS STEEL CORE WIRE. UNDER MAGNIFICATION THERE WAS PROXIMAL GLUE FILLET RESIDUE ON THE NITINOL SLEEVE AND THE STAINLESS STEEL CORE WIRE. THERE WAS A GAP IN THE HYDROPHILIC COATING IMMEDIATELY ADJACENT TO THE NITINOL SLEEVE THAT INDICATES THE GLUE FILLET WAS IN PLACE DURING MANUFACTURING. THE NITINOL TUBING DID NOT TORQUE FREELY AND THE DEVICE TORQUE WAS ONE TO ONE. NO OTHER ANOMALIES WERE NOTED TO THE DEVICE. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE COATING WAS PEELING IN A REGION FROM 29CM TO 34CM FROM THE PROXIMAL END. THE PTFE COATING WAS PEELED ON ONE SIDE OF THE DEVICE IN FOUR PLACES IN THIS REGION. THERE WERE INDICATIONS THAT THE PTFE COATING HAD BEEN SCRAPED BY THE TORQUE DEVICE. THIS TYPE OF DAMAGE IS INDICATIVE THAT THE TORQUE DEVICE WAS NOT SUFFICIENTLY TIGHTENED ONTO THE DEVICE. THE DIRECTIONS FOR USE STATE: "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)". THE CASE OF THE DAMAGE TO THE PTFE COATING IS DUE TO USER ERROR.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING FROM PROXIMAL SECTION OF THE DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVS 2000 SYNCHRO2 GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY M00326110 B20654

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR