BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 3841032 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03468
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED. THE DIFFICULT TO POSITION, DIFFICULT TO REMOVE AND DEVICE OPERATES DIFFERENTLY (STICKY), WERE NOT CONFIRMED. BASED ON THE VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS DURING A PROCEDURE OF THE DIAGONAL ARTERY THE XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) MET RESISTANCE AND COULD NOT BE ADVANCED OVER THE DISTAL 3-4 CM OF THE GUIDE WIRE AND THE GUIDE WIRE FELT STICKY. THE TWO DEVICES WERE REMOVED AS A SYSTEM AND THE GUIDE WIRE WAS WIPED DOWN THEN REINSERTED INTO THE SDS, HOWEVER, RESISTANCE WAS MET AND THE DEVICES WERE NOT USED IN THE PROCEDURE. A NON-ABBOTT GUIDE WIRE WAS USED WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317997 HI-TORQUE WHISPER ES GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 4030571

    Patients

    Seq Age Sex Outcome Treatment
    1