BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V18 CONTROL WIRE

    MDR report key: 1060061 · Received June 11, 2008

    Report

    Report Number
    2134265-2008-01656
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE GUIDE WIRE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT GUIDE WIRE 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RENAL INTERVENTION PROCEDURE, DAMAGE TO THE GUIDE WIRE COATING OCCURRED. THE DE NOVO LESION OF UNKNOWN CALCIFICATION AND TORTUOUSITY WAS LOCATED IN THE RENAL ARTERY. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE COATING ON THE DISTAL TIP OF THE V18 CONTROL WIRE HAD SEPARATED AND LOOKED TO BE "SCRUNCHED." IT WAS REPORTED THAT NO COATING WAS RETAINED IN THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V18 CONTROL WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA 11427750

    Patients

    Seq Age Sex Outcome Treatment
    1