BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3143496 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03467
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 16, 2013
    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: RUNTHROUGH; GUIDE CATH: PROFIT 6F AL1, REVOLUTION. 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. REVIEW OF THE COMPLAINT HISTORY OF 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 DURING THE PROCEDURE IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED DISTAL CIRCUMFLEX ARTERY FOR TREATMENT OF A 99% DE NOVO LESION, A 1.20X6 RX MINI TREK DILATATION CATHETER WAS DELIVERED WITHOUT RESISTANCE VIA RADIAL ACCESS. DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS WITHDRAWN WITHOUT RESISTANCE FROM THE ANATOMY AND EXCHANGED FOR A NON-ABBOTT DILATATION CATHETER. THIS BALLOON ALSO RUPTURED. A THIRD BALLOON (NON-ABBOTT) WAS USED SUCCESSFULLY TO PERFORM DILATATION. INTRAVASCULAR ULTRASOUND WAS PERFORMED AND A NON-ABBOTT STENT WAS IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243481 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20919G1

    Patients

    Seq Age Sex Outcome Treatment
    1