BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3143156 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03457
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 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). 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 THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS 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 TORTUOSITY, MODERATELY CALCIFIED, ECCENTRIC, 99% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA). THE 2.0X15 MM MINI TREK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED AT THIRD INFLATION AT 12 ATMOSPHERES. THE FIRST AND SECOND INFLATION WAS 10 TO 12 ATMOSPHERES FOR 30 TO 60 SECONDS. THERE WAS A LITTLE RESISTANCE WITH THE CALCIFIED LESION DURING ADVANCEMENT AND NO RESISTANCE NOTED DURING REMOVAL OF THE DEVICE. AFTER THE BALLOON RUPTURE, NO ADDITIONAL PRE-DILATATION WAS PERFORMED. IT WAS NOTED THAT THE DEVICE WAS SOAKED IN THE NORMAL SALINE DURING PREPARATION. 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
    243789 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20911G1

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION BLUE