BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 1161558 · Received September 15, 2008

    Report

    Report Number
    2134265-2008-02647
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILLED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTEGRADE BILIARY STENTING PROCEDURE, DAMAGE TO THE GUIDEWIRE OCCURRED. THE DE NOVO PREDILATED LESION WAS 80% STENOSED, MODERATELY TORTUOUS, MODERATELY CALCIFIED AND LOCATED IN THE COMMON BILE DUCT (CBD). DURING THIS PROCEDURE, A WALLSTENT WAS INTRODUCED OVER THE WIRE, BUT THE ZIPWIRE AND THE WALLSTENT 'STUCK TOGETHER". THE PHYSICIAN WITHDREW BOTH THE WIRE AND THE STENT. THE PHYSICIAN NOTED THAT THE HYDROPHILIC COATING ON THE ZIPWIRE WAS 'CRACKLED". THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY USING A NEW ZIPWIRE AND WALLSTENT. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE HYDROPHILIC GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA M1984221

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR