BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 4042178 · Received August 27, 2014

    Report

    Report Number
    2024168-2014-05496
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 5, 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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS 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 DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING A CATHETER OVER A WHISPER ES GUIDE WIRE. THE GUIDE WIRE FELT STICKY. THERE WAS ALSO DIFFICULTY REMOVING THE CATHETER FROM THE GUIDE WIRE. A NON-ABBOTT GUIDE WIRE WAS SUCCESSFULLY USED WITH THE SAME CATHETER 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
    520581 HI-TORQUE WHISPER ES GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1