BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 4021388 · Received August 19, 2014

    Report

    Report Number
    2024168-2014-05312
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 30, 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 MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE, GUIDE CATH: HYPERION SAL1.0 7FR. 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 99% STENOSED LESION IN THE DISTAL CIRCUMFLEX ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. THE 1.2 X 6 MM MINI TREK BALLOON CATHETER WAS ADVANCED, BUT MET RESISTANCE WITH THE LESION. THE MINI TREK WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE. AFTER REMOVAL, IT WAS FOUND THAT HALF OF THE DISTAL TIP WAS TORN. THERE WAS NO PORTION OF THE TIP MISSING. A NEW TREK BALLOON CATHETER WAS USED WITHOUT ISSUE. 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
    497863 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40329G2

    Patients

    Seq Age Sex Outcome Treatment
    1