BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE SS GUIDEWIRE

    MDR report key: 732726 · Received July 5, 2006

    Report

    Report Number
    6000130-2006-00166
    Event Type
    Injury
    Date Received
    July 5, 2006
    Date of Event
    June 2, 2006
    Report Date
    June 5, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETRUNED FOR EVALUATION; A THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SFP COULD NOT BE EXAMINED. SHOUL FURTHER RELEVANT INFORMAITON BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTA TREATMENT PROCEDURE INVOLVING A FISTULA LESION IN THE PATIENT'S ARM, THE ZIPWIRE BECAME STUCK IN THE BALLOON. THE WIRE AND BALLOON WERE REMOVED AS A UNIT, BUT THIS MANEUVER INCREASED THE SIZE OF THE EXIT SITE IN THE PATIENT'S ARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A "OKAY," WITHOUT PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE SS GUIDEWIRE PTA GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other