BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES

    MDR report key: 2063202 · Received April 19, 2011

    Report

    Report Number
    2939204-2011-00208
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLE AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. THE GUIDEWIRE WAS RETURNED FOR ANALYSIS. VISUALLY INSPECTION FOUND A CLEAR SUBSTANCE RESEMBLING A BLISTER ON THE DISTAL TIP. THE OUTER DIAMETER OF THE GUIDEWIRES DISTAL TIP MEASURED .0141 CM. THERE WAS A WHITISH GREEN, BUBBLY AND BLISTERED SUBSTANCE ON THE GUIDEWIRE NITINOL 0.5CM, 12.0CM, 14.5CM AND 24.5CM FROM ITS DISTAL END. THE COATING WAS CHECKED AND THEIR APPEARED TO BE EXCESSIVE HYDROPHILIC COATING ON THE GUIDEWIRE DISTAL SECTION. THE GUIDEWIRE NITINOL TUBING WAS SEPARATED ON ITS DISTAL SECTION AT 0.5CM AND 0.7CM FROM THE DISTAL END. THE PLATINUM COIL WAS SLIGHTLY STRETCHED, AND THE CORE WIRE WAS BENT AT THE SEPARATED SECTION. ALTHOUGH WE PERFORMED AN ANALYSIS OF THE PRODUCT, THE CAUSE OF THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THE INVESTIGATION WAS UNABLE TO IDENTIFY ANY FAILURE OF THE PRODUCT TO MEET ITS MATERIAL, ASSEMBLY OR PERFORMANCE SPECIFICATIONS. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE TIP BREAK.

    Description of Event or Problem · 1

    BASED ON ANALYSIS OF THE DEVICE, THE GUIDEWIRE WAS NOTED TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY M00313010 B21099

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR