BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT COMMAND

    MDR report key: 2800333 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06649
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. DIL CATH: MINI TREK; SHEATH: 5F TERUMO 55 CM. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE MINI TREK IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WITH THE CATHETER WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, AND 100% STENOSED ANTERIOR TIBIA ARTERY. A 2.0 X 20 MM MINI TREK BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE TO THE LESION WITHOUT RESISTANCE; HOWEVER, AS THE BALLOON CATHETER REACHED THE LESION, IT COULD NOT MOVE FORWARD OR BACKWARD OVER THE GUIDE WIRE. THE DEVICES WERE REMOVED AS A SINGLE UNIT. A NEW COMMAND GUIDE WIRE AND MINI TREK WERE USED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT COMMAND GUIDE WIRE DQX AV-TEMECULA-CT 2082001

    Patients

    Seq Age Sex Outcome Treatment
    1