BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ UROLOGICAL GUIDEWIRE

    MDR report key: 1082651 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01242
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 UROLOGICAL PROCEDURE THE GUIDEWIRE TIP FRAYED. AN AMPLATZ PTFE.035 STR GUIDEWIRE HAD BEEN ADVANCED TO AN UNSPECIFIED LOCATION. THE PHYSICIAN HAD ADVANCED A UNK TYPE "J DOUBLE CATHETER" OVER THE GUIDEWIRE. THE TIP OF THE GUIDEWIRE APPEARED "FRAYED" AT AN UNSPECIFIED TIME DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN UNK TYPE GUIDEWIRE INCLUDED WITH THE "J DOUBLE CATHETER". THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1