BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER GUIDE WIRE

    MDR report key: 3140875 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03430
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 3.0 X 23 MM XIENCE V REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. DIFFICULT TO POSITION/DIFFICULT TO REMOVE (GUIDE WIRE RESISTANCE) WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT IDENTIFICATION NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A 3.0 X 23 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED OVER A WHISPER GUIDE WIRE, THE CATHETER STUCK ON THE GUIDE WIRE AND WHEN ATTEMPTING TO CONTINUE TO ADVANCE THE SDS, THE BALLOON SEPARATED FROM THE OUTER MEMBER BEFORE THE SDS ENTERED THE ANATOMY. THE INNER MEMBER REMAINED INTACT. THE SDS AND THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT AND THE A NEW XIENCE V AND WHISPER GUIDE WIRE WERE SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243962 HI-TORQUE WHISPER GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 3.0 X 23 MM XIENCE V