BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2911400 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00246
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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. 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 MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, AND 100% STENOSED PROXIMAL RIGHT CORONARY ARTERY. A 1.20 X 6 MM MINI TREK BALLOON CATHETER WAS ADVANCED TO THE LESION WITH STRONG RESISTANCE. WHILE BEING PRESSURIZED, THE BALLOON RUPTURED AT 6 ATMOSPHERES. A NEW TREK WAS USED FOR PRE DILATATION AND A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17535 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20630G3

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RUNTHROUGHGUIDE CATH: HEARTRAIL