BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3930129 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04462
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 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). 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 COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. 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 MILDLY TORTUOUS, MODERATELY CALCIFIED, CONCENTRIC, 99% STENOSIS IN THE PROXIMAL CIRCUMFLEX. REPORTEDLY, THE 1.2 X 6MM RX TREK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION; HOWEVER, DURING FIRST INFLATION, THE BALLOON FAILED TO INFLATE. A SECOND 1.2 X 6MM RX TREK BALLOON CATHETER WAS USED TO COMPLETE PRE-DILATATION. THE PROCEDURE WAS COMPLETED AFTER DEPLOYMENT OF A NON-ABBOTT STENT. NO RESISTANCE WAS FELT DURING ADVANCEMENT TO THE LESION. 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
    407973 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40219G2

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR GUIDE WIRE: INTEC SION BLUE,XT-R