BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT COMMAND

    MDR report key: 4133780 · Received October 1, 2014

    Report

    Report Number
    2024168-2014-06349
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A DE NOVO LESION IN THE ANTERIOR TIBIAL ARTERY WITH MILD TORTUOSITY, HEAVY CALCIFICATION AND 99% STENOSIS, A HT COMMAND GUIDE WIRE WAS ADVANCED AND ATTEMPTED TO CROSS THE LESION; HOWEVER, THE GUIDE WIRE BECAME STUCK. THE HT COMMAND GUIDE WIRE WAS WITHDRAWN WITH RESISTANCE FROM THE PATIENT ANATOMY AND THE COIL WAS STRETCHED. REPORTEDLY, THE GUIDE WIRE COILS REMAINED COMPLETELY INTACT WITH NO SEPARATION NOTED. A NEW HT COMMAND GUIDE WIRE WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611730 HT COMMAND GUIDE WIRE DQX AV-TEMECULA-CT 4052271

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR