BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVS 2000 SYNCHRO2 GUIDEWIRE

    MDR report key: 2083433 · Received May 10, 2011

    Report

    Report Number
    2939204-2011-00296
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 6, 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. INSPECTION OF THE RETURNED DEVICE NOTED IT WAS SLIGHTLY BENT 5.6CM FROM THE PROXIMAL END. THE PTFE COATING WAS OBSERVED TO BE COMPRESSED AND SCRAPED 35CM FROM THE PROXIMAL END. THE TORQUE DEVICE BRASS COLLET MARKINGS WERE SEEN ON THE DEVICE, WHICH IS INDICATIVE OF THE TORQUE DEVICE HAVING BEEN DRAGGED DOWN THE DEVICE. NO OTHER ANOMALIES WERE NOTED. FROM THE CONDITION OF THE DEVICE, THE TORQUE DEVICE HAD NOT BEEN SECURELY TIGHTENED ONTO THE DEVICE. AS THE DIRECTION FOR USE SPECIFICALLY CAUTIONS THAT INSUFFICIENT TIGHTENING OF THE TORQUE DEVICE CAN LEAD TO PTFE PEELING, THE CAUSE IS CONSIDERED TO BE USE/USER RELATED.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING ON THE PROXIMAL END. THERE WAS NO 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 M00326010 B21692

    Patients

    Seq Age Sex Outcome Treatment
    1