BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT COMMAND

    MDR report key: 3870147 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03761
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED COATING DAMAGE WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR COATING DAMAGE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIRST HT COMMAND GUIDE WIRE MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE GUIDE WIRE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE FIRST HT-COMMAND GUIDE WIRE WAS BEING SHAPED WITH AN INSERTION TOOL, BLACK POWDERY SUBSTANCE WAS FOUND ADHERED TO THE PHYSICIAN'S GLOVE. THE GUIDE WIRE WAS NOT USED. WHEN THE SECOND HT-COMMAND GUIDE WIRE WAS BEING SHAPED WITH AN INSERTION TOOL, BLACK POWDERY SUBSTANCE WAS AGAIN FOUND ADHERED TO THE PHYSICIAN'S GLOVE. THE TIP WAS EXAMINED AND IT APPEARED THAT THE POLYMER COATING WAS SCRAPED. THE GUIDE WIRE WAS NOT USED. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346816 HT COMMAND GUIDE WIRE DQX AV-TEMECULA-CT 3060571

    Patients

    Seq Age Sex Outcome Treatment
    1