BEUDAMED
    FDA Adverse Event Summary report: N

    AMPLATZ GUIDEWIRE

    MDR report key: 1083583 · Received July 24, 2008

    Report

    Report Number
    3005099803-2008-01278
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 AN UNSPECIFIED PROCEDURE, GUIDE WIRE DAMAGE OCCURRED. THE LOCATION OF THE LESION IS UNK. THE 0.035 AMPLATZ GUIDE WIRE WAS INSERTED AND AN UNSPECIFIED DOUBLE J CATHETER WAS PLACED. AT AN UNSPECIFIED TIME, THE TIP OF THE GUIDE WIRE FRAYED. THE GUIDE WIRE WAS REMOVED AND IT WAS NOTED THAT THE GUIDE WIRE DID NOT BREAK NOR WERE ANY PIECES LEFT INSIDE THE PT. THE PROCEDURE WAS COMPLETED WITH THE GUIDE WIRE THAT ACCOMPANIED THE DOUBLE J SET. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ GUIDEWIRE KOG BOSTON SCIENTIFIC M0066401041 11470478

    Patients

    Seq Age Sex Outcome Treatment
    1