BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 6638138 · Received June 13, 2017

    Report

    Report Number
    2024168-2017-05032
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 13, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648151866
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION GUIDE CATHETER: HYPERION STENT: XA2.5-23. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TWO LESIONS. THE FIRST WAS A CONCENTRIC DE NOVO LESION LOCATED IN THE MID-RIGHT CORONARY ARTERY (RCA) THAT WAS MODERATELY TORTUOUS, MILDLY CALCIFIED AND 90% STENOSED. THE SECOND WAS A CONCENTRIC DE NOVO LESION LOCATED IN THE DISTAL RCA THAT WAS MODERATELY TORTUOUS, MILDLY CALCIFIED AND 90% STENOSED. THE NC TREK RX 3.0 X 12 MM BALLOON DILATATION CATHETER WAS BEING USED FOR POST-DILATATION OF A DEPLOYED STENT AND HAD DIFFICULTY CROSSING THE TORTUOUS VESSEL, AND INSIDE THE DEPLOYED STENT, HOWEVER SUCCESSFULLY CROSSED. WHEN INFLATED FOR THE FIRST TIME, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED FROM THE ANATOMY AND WAS REPLACED WITH A NON-ABBOTT BALLOON DILATATION CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419956 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 70315G1 08717648151866

    Patients

    Seq Age Sex Outcome Treatment
    1