BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3924290 · Received July 9, 2014

    Report

    Report Number
    2024168-2014-04426
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MODERATELY CALCIFIED, DE NOVO IN THE DISTAL RIGHT CORONARY ARTERY. REPORTEDLY, THE 2.5 X 15MM RX TREK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 14 ATMOSPHERES. A SECOND 2.5 X 15MM RX TREK BALLOON CATHETER WAS USED. A 3.5 X 15MM NC TREK BALLOON TO BE USED FOR POST-DILATATION WAS FOUND KINKED BEFORE INSERTING INTO THE PATIENT ANATOMY AND WAS NOT USED. 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
    400631 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40217G1

    Patients

    Seq Age Sex Outcome Treatment
    1