BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEIER GUIDE WIRES

    MDR report key: 2830326 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-06873
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K011906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR INTERVENTION, GUIDEWIRE DAMAGE OCCURRED. AN EVAR (ENDOVASCULAR AORTIC REPAIR) PROCEDURE WAS PERFORMED USING BACK UP MEIER GUIDEWIRE WHEN PLACING AN ABDOMINAL AORTIC ANEURYSMS (AAA) NON BSC GRAFT. TWO BACK UP MEIER GUIDEWIRES WAS USED AND WHEN WITHDRAWING ONE OF THEM SOME RESISTANCE WAS FELT. THEREFORE, NURSE CHECKED THE WIRE WHEN WITHDRAWN AND SAW THAT THE COATING WAS PARTLY SCRATCHED/PEELED OFF FROM THE WIRE ALMOST HALF OF THE WIRE LENGTH WAS IN THIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEIER GUIDE WIRES WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H965SCH306010

    Patients

    Seq Age Sex Outcome Treatment
    1