BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3853825 · Received June 6, 2014

    Report

    Report Number
    2024168-2014-03633
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 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 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 UNSPECIFIED TARGET LESION WAS HEAVILY CALCIFIED. THE NC TREK 3.0 X 15 MM BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). THE PROCEDURE WAS CONTINUED AND A NON-ABBOTT 3.0 X 24 MM STENT WAS IMPLANTED IN THE TARGET LESION. THE PHYSICIAN COMMENTED THAT AS THE VESSEL WAS HEAVILY CALCIFIED, THE BALLOON RUPTURE OCCURRED DUE TO THE HEAVY CALCIFICATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332014 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31220G1

    Patients

    Seq Age Sex Outcome Treatment
    1