BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4190276 · Received October 21, 2014

    Report

    Report Number
    2024168-2014-06861
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SEPARATION WAS CONFIRMED. THE REPORTED RESISTANCE DURING REMOVAL COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL 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 THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION LOCATED IN THE RIGHT CORONARY ARTERY. AFTER DEPLOYMENT OF TWO STENTS IN AN OVERLAPPING FASHION AT THE LESION, THE 2.5 X 25 MM NC TREK WAS BEING USED FOR POST-DILATATION OF THE STENTS. AFTER INFLATION AND DEFLATION OF THE BALLOON, THE BALLOON CAUGHT ON AN OVERLAPPING STENT STRUT DURING RETRACTION CAUSING THE PROXIMAL SHAFT OF THE BALLOON CATHETER TO SEPARATE. THE POST-DILATATION WAS CONSIDERED SUCCESSFUL AND ALL DEVICES WERE REMOVED FROM THE ANATOMY AS ONE UNIT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668680 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 4061961

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR