BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 6281492 · Received January 26, 2017

    Report

    Report Number
    2024168-2017-00703
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    January 19, 2017
    Report Date
    January 26, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648152092
    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 BLUE, SION BLACK, GUIDE CATHETER: HYPERION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 A HEAVILY TORTUOUS AND HEAVILY CALCIFIED, 90% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 4.5X8 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION; HOWEVER, RESISTANCE WAS MET WITH THE ANATOMY. DURING THE FIRST INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE NC TREK RX BDC WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT RESISTANCE AND AN UNSPECIFIED BDC WAS USED FOR PRE-DILATATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER IMPLANTATION OF AN UNSPECIFIED XIENCE ALPINE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64877 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50812G1 08717648152092

    Patients

    Seq Age Sex Outcome Treatment
    1