BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3813322 · Received May 15, 2014

    Report

    Report Number
    2024168-2014-03078
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    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). 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 ASSOCIATED NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR MATERIAL RUPTURE 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 MILDLY TORTUOUS, MILDLY CALCIFIED, CONCENTRIC, 90% STENOSED, DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A 3.5X38 MM XIENCE XPEDITION WAS IMPLANTED BY DIRECT STENTING AND THE 3.75X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION. THE BALLOON WAS INFLATED TO 12 ATMOSPHERES (ATM) ON THE FIRST INFLATION. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 12 ATM. ADDITIONAL POST-DILATATION WAS THEN PERFORMED WITH A NON-ABBOTT BDC. 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
    289335 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2082861

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 3.5 X 38 MM XIENCE XPEDITION