BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3601810 · Received January 31, 2014

    Report

    Report Number
    2024168-2014-00556
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MODERATELY TORTUOUS, 70% STENOSED, MID RIGHT CORONARY ARTERY. NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE 4.0X30 MM TREK BALLOON CATHETER TO THE LESION; HOWEVER, UPON INFLATION, A LEAK WAS OBSERVED IN THE SHAFT OF THE DEVICE. ANOTHER TREK BALLOON WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67589 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21106G2

    Patients

    Seq Age Sex Outcome Treatment
    1