BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM

    MDR report key: 2771020 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06256
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    August 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K083706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT - ESTIMATED. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY 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 THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED FEMORAL ARTERY. ATTEMPTS TO CROSS THE LESION WERE UNSUCCESSFUL DUE TO THE CALCIFIED LESION. THE GUIDE WIRE WAS BEING ADVANCED AGAINST PLAQUE, WHEN A SEPARATION AT ABOUT 5 TO 10 CENTIMETERS FROM THE TIP WAS OBSERVED ON X-RAY. AFTER RETRACTION OF THE GUIDE WIRE FROM THE PATIENT'S ANATOMY, THE DISTAL END OF THE GUIDE WIRE WAS OBSERVED TO BE KINKED WITH A NOTICEABLE SEPARATION; HOWEVER, IT WAS STATED THAT IT WAS NOT FULLY SEPARATED. A NEW NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1