BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3841378 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03481
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 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 NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR BALLOON RUPTURE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE NC TREK REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, 75% STENOSED, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE 3.0 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS POSITIONED AND DURING THE FIRST PREDILATATION INFLATION AT 12 ATMOSPHERE (ATM) THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE AND A SECOND 3.0 X 12 MM NC TREK WAS USED TO COMPLETE THE PREDILATATION. THE 3.5 X 33 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE THE ANATOMY. IT WAS NOTED THAT THE DISTAL SHAFT WAS KINKED AND THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. A SECOND XIENCE XPEDITION STENT WAS DEPLOYED AT THE LESION. AS A ROUTINE PROCEDURE A 3.5 X 12 MM NC TREK BDC WAS USED FOR POST-DILATATION, HOWEVER, DURING THE FIRST INFLATION ATTEMPT THE BALLOON RUPTURED AT 8 ATM. A SECOND 3.5 X 12 MM NC TREK BDC WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. 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
    318846 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30716G2

    Patients

    Seq Age Sex Outcome Treatment
    1