BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 4081707 · Received September 11, 2014

    Report

    Report Number
    2024168-2014-05815
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 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). CONCOMITANT PRODUCTS: GUIDE WIRE: SION, XT-R, GAIA; GUIDE CATH: LAUNCHER. 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/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 THE PROCEDURE WAS TO TREAT A 99% STENOSED, HEAVILY CALCIFIED LESION IN THE MODERATELY TORTUOUS DISTAL CIRCUMFLEX (CX) ARTERY. THE 1.20X6MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED AND PREPPED PRIOR TO USE WITH NO ISSUES OR LEAKS NOTED. AFTER PLACEMENT OF A NON-ABBOTT GUIDE WIRE, THE MINI TREK BDC WAS ADVANCED TO THE TARGET LESION; HOWEVER, THERE WAS RESISTANCE NOTED WITH THE ANATOMY DURING ADVANCEMENT. DURING THE FIRST INFLATION, THE MINI TREK BALLOON RUPTURED AT 6 ATMOSPHERES (ATM) AND THE BDC WAS REMOVED WITHOUT RESISTANCE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. PRE-DILATATION WAS PERFORMED USING TWO NON-ABBOTT BDCS, FOLLOWED BY DEPLOYMENT OF A XIENCE XPEDITION STENT IMPLANT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562083 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40111G1

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES