BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2893660 · Received January 2, 2013

    Report

    Report Number
    2024168-2013-00008
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 19, 2012
    Report Date
    December 10, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A USER FACILITY MEDWATCH REPORT THAT THE PATIENT WAS UNDERGOING AN ABDOMINAL AORTOGRAM WITH RIGHT LOWER EXTREMITY RUNOFF. THE WHISPER MS GUIDE WIRE WAS DIRECTED DOWN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE INITIAL SHEATH WAS NOT ABLE TO BE CORRECTED DOWN THE SFA AND WAS REMOVED AND REPLACED WITH A 6 FRENCH RADIAL ACCESS SHEATH WITH A 0.014 LUMEN. AS THE NEW SHEATH WAS INTRODUCED OVER THE WHISPER GUIDE WIRE, THE SHEATH SHEARED THE GUIDE WIRE IN TWO PIECES, LEAVING A PIECE IN THE FEMORAL VESSEL. THE PATIENT WAS SENT FOR SURGERY FOR REMOVAL OF THE SEPARATED SEGMENT. THE PATIENT HAS SINCE BEEN DISCHARGED IN GOOD HEALTH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 2083171

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SHEATH: 6 FRENCH