BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3874439 · Received June 16, 2014

    Report

    Report Number
    2024168-2014-03857
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: GAIA 1ST, GAIA 2ND, SION BLUE ; OTHER: CORSAIR. 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 TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH MILD TORTUOSITY, HEAVY CALCIFICATION AND 100% STENOSIS. THE 1.2 X 6 MM RX MINI TREK BALLOON WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE MINI TREK BALLOON RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES (ATM). A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE MINI TREK BALLOON HAD BEEN PREPARED, PER THE INSTRUCTIONS FOR USE. THERE WAS 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
    353514 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20622G1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR