BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT COMMAND

    MDR report key: 3171179 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03762
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE ADDITIONAL HI-TORQUE COMMAND GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH TO THE NARROW, LEFT LOWER, ANTERIOR TIBIAL ARTERY THE HI-TORQUE COMMAND GUIDE WIRE WAS UTILIZED BUT BECAME MALFORMED DURING USE AND WAS REMOVED WITHOUT REPORTED ISSUE. A SECOND HI-TORQUE COMMAND GUIDE WIRE WAS UTILIZED IN THE ANGIOPLASTY PROCEDURE BUT ALSO BECAME MALFORMED DURING USE AND A DIFFERENT COMMAND GUIDE WIRE HAD TO BE USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271302 HT COMMAND GUIDE WIRE DQX AV-TEMECULA-CT 3012171

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR