BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V18 CONTROL WIRE

    MDR report key: 1032885 · Received April 23, 2008

    Report

    Report Number
    2134265-2008-01167
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RENAL STENTING PROCEDURE, GUIDE WIRE DAMAGED AND A FOREIGN MATERIAL ON THE GUIDE WIRE WAS NOTED. THE LESION WAS LOCATED IN A NON-CALCIFIED AND NON-TORTUOUS RENAL ARTERY. A STENT WAS INSERTED OVER THE GUIDE WIRE AND BOTH DEVICES WERE REMOVED FROM THE PATIENT. ACCORDING TO THE CUSTOMER, THE CHOICE GUIDE WIRE WAS "MALFORMED" AND THAT THERE WAS A "BLOB" AT THE JUNCTION OF THE DISTAL TIP. A NEW GUIDE WIRE WAS USED AND THE STENT WAS SUCCESSFULLY DEPLOYED. THE CUSTOMER ADDITIONALLY REPORTED THAT THIS WAS A "COMPLICATED RENAL CANNULATION" AND "HAVING TO PULL WIRE OUT LENGTHENED CASE GREATLY." NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS 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 11205501

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR