BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 1040187 · Received May 8, 2008

    Report

    Report Number
    2134265-2008-01338
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDE WIRE 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 FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOUR VESSEL TREATMENT PROCEDURE, THE COATING OF THE ZIPWIRE HYDROPHILIC GUIDE WIRE "PEELED OFF." THE LESION WAS LOCATED IN THE COMMON CAROTID ARTERY. THE DETACHED COATING CREATED AN OCCLUSION IN THE PT. THIS WAS RESOLVED IN APPROXIMATELY 30 MINUTES FOLLOWING TREATMENT WITH UROKINASE. IT WAS FURTHER REPORTED THAT NO COATING WAS LEFT IN THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PT COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "NORMAL." ADD'L INFO HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE HYDROPHILIC GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA 0002995098

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention 0.035 150CM TERUMO GUIDEWIRE