BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT COMMAND

    MDR report key: 3964425 · Received July 29, 2014

    Report

    Report Number
    2024168-2014-04839
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DURING A TIBIAL ANGIOPLASTY PROCEDURE TO TREAT A LESION IN THE MID ANTERIOR TIBIAL ARTERY, A HT COMMAND GUIDE WIRE WAS PREPPED PER THE INSTRUCTIONS FOR USE AND WAS ADVANCED TO ACCESS THE LESION. UPON INSERTING A 0.014 NON-ABBOTT BALLOON CATHETER SLIGHT RESISTANCE ON THE PROXIMAL STAINLESS STEEL PORTION OF THE GUIDE WIRE WAS FELT; HOWEVER, THE BALLOON ADVANCED DOWN THE ANATOMY. AFTER INFLATION AND DEFLATION OF THE BALLOON, AN ATTEMPT WAS MADE TO REMOVE THE BALLOON FROM THE GUIDE WIRE AND THE BALLOON COULD NOT COME OFF THE GUIDE WIRE AT THE PROXIMAL PORTION OF THE GUIDE WIRE (ALL OUTSIDE OF THE PATIENT ANATOMY). THE BALLOON CATHETER WAS TORN OFF OF THE GUIDE WIRE AND THE PHYSICIAN ASSUMED IT WAS THE BALLOON THAT WAS DEFECTIVE AND CONTINUED TO USE THE HT COMMAND GUIDE WIRE WITH AN 0.014 DRUG-ELUTING BALLOON; HOWEVER, THE SAME RESISTANCE WAS FELT DURING ADVANCEMENT AT THE PROXIMAL PORTION OF THE GUIDE WIRE. THE BALLOON DID ADVANCE TO THE LESION AND WAS INFLATED, DEFLATED AND REMOVED FROM THE PATIENT ANATOMY; HOWEVER, THE BALLOON BECAME STUCK ON THE GUIDE WIRE AT THE PROXIMAL PORTION OF THE GUIDE WIRE. THE BALLOON WAS AGAIN TORN OFF OF THE GUIDE WIRE AND THE GUIDE WIRE WAS WITHDRAWN FROM THE PATIENT ANATOMY AND DISCARDED. A 0.014 GUIDE WIRE WAS THEN USED AND AN 0.014 NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. REPORTEDLY, THE PHYSICIAN THOUGHT THAT THE HT COMMAND GUIDE WIRE WAS LARGER THAN 0.014 AT SOME POINT ON THE PROXIMAL END OF THE GUIDE WIRE AS TWO DIFFERENT BALLOONS COULD NOT PASS OVER THE WIRE. 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
    441112 HT COMMAND GUIDE WIRE DQX AV-TEMECULA-CT 4032171

    Patients

    Seq Age Sex Outcome Treatment
    1 DILATATION CATHETER: 014 COYOTE