BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT COMMAND

    MDR report key: 3882059 · Received June 18, 2014

    Report

    Report Number
    2024168-2014-03912
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. 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 THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED MID ANTERIOR TIBIAL ARTERY. THE TRANSITION POINT OF THE HT COMMAND ES WIRE 300CM (THE JOINT BETWEEN THE STAINLESS STEEL AND NITINOL) BROKE INTO 2 PIECES DURING REMOVAL OF TRAILBLAZER SUPPORT CATHETER. THERE WAS NO RESISTANCE FELT BETWEEN THE SUPPORT CATHETER AND THE GUIDE WIRE DURING REMOVAL. THE BREAKAGE OCCURRED OUTSIDE OF THE PATIENT ANATOMY AFTER THE GUIDE WIRE WAS COMPLETELY REMOVED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359309 HT COMMAND GUIDE WIRE DQX AV-TEMECULA-CT 3061171

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: TRAILBLAZER SUPPORT CATHETER