BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3936181 · Received July 15, 2014

    Report

    Report Number
    2024168-2014-04532
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 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: SION BLUE, GAIA 1ST, CONQUEST PRO; GUIDE CATH: TAIGA 6FR EBU3.5. 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 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 USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE CONCENTRIC, HEAVILY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED, CHRONIC TOTAL OCCLUSION BELOW THE BIFURCATION OF THE RIGHT CORONARY ARTERY (RCA) DURING THE PRE-DILATATION FIRST INFLATION ATTEMPT WITH A 1.50 X 15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) THE BALLOON RUPTURED AT 7 ATMOSPHERE (ATM). ALTHOUGH THERE WAS NOTED RESISTANCE DURING ADVANCING THE BDC AND NONE DURING REMOVAL OF THE DEVICE, THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A 2.0 X 15 MM NON-ABBOTT BDC WAS PERFORMED THEN A 2.0 X 8 MM TREK BDC WAS COMPLETED. IT WAS NOTED THAT INTRAVASCULAR ULTRASOUND (IVUS) DID NOT CROSS THE LESION AND THE STENT IMPLANT WAS ABANDONED AND THE PROCEDURE WAS CONCLUDED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412193 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20713G1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR