BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3964966 · Received July 29, 2014

    Report

    Report Number
    2024168-2014-04846
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF DISSECTION AND OCCLUSION, AS LISTED IN THE JAPAN RX TREK CORONARY DILATATION CATHETER, INSTRUCTIONS FOR USE, ADVERSE EFFECTS SECTION, ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF A BALLOON DILATATION CATHETER IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC 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 THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS 90% STENOSIS IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. REPORTEDLY, AFTER AN INTRAVASCULAR ULTRASOUND (IVUS), DURING PRE-DILATATION THE 2.0 X 15MM RX TREK BALLOON CATHETER WAS INFLATED TO 3 ATMOSPHERES DISTAL OF THE LESION. THE RX TREK WAS PULLED PROXIMAL OF THE LESION AND INFLATED TO 6 ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED. A CORONARY DISSECTION AT THE LESION AND SIDE BRANCH DISAPPEARANCE OCCURRED. TWO PLANED NON-ABBOTT DRUG ELUTING STENTS WERE PLACED AT THE LESION AND THE PROCEDURE WAS COMPLETED. 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
    441463 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40409G1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: SION BLUE