BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PROGRESS GUIDE WIRE

    MDR report key: 3082766 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02648
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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 TREATMENT OF A CHRONIC TOTALLY OCCLUDED LESION WITH HEAVY CALCIFICATION, THE TIP OF THE PROGRESS GUIDE WIRE WAS TOO STIFF AND THE POLYMER COVER MAKES THE GUIDE WIRE SLIPPERY, WHICH CAUSED A DISSECTION. THE DISSECTION WAS TREATED WITH STENT IMPLANTATION. THE PATIENT WAS TREATED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184632 HI-TORQUE PROGRESS GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention