BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE FLOPPY II GUIDE WIRE

    MDR report key: 3954000 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04737
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 30, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDSUN REPORT RECEIVED ON (B)(4) 2014: THE HI-TORQUE FLOPPY II 190CM WIRE WAS ENTERED INTO THE PATIENT AND USED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). ONCE THE WIRE WAS REMOVED OUT OF PATIENT'S BODY, THE PHYSICIAN DISCOVERED THE WIRE HAD SPLIT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431753 ACS HI-TORQUE FLOPPY II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1