BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 8450037 · Received March 25, 2019

    Report

    Report Number
    2024168-2019-02307
    Event Type
    Malfunction
    Date Received
    March 25, 2019
    Date of Event
    February 27, 2019
    Report Date
    March 25, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648138140
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE, AMATI; GUIDE CATHETER: HYPERION AL 6 F; OTHER: INTRAVASCULAR ULTRASOUND. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT MAY HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED, CONCENTRIC DE NOVO LESION IN THE POSTERIOR DESCENDING BRANCH THAT WAS 90% STENOSED. DURING ADVANCEMENT OF A 2.0X12MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) RESISTANCE WAS MET WITH THE ANATOMY, BUT THE BDC ULTIMATELY REACHED THE LESION. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES FOR 5 SECONDS. THE BDC WAS REPLACED WITH A 2.5MM NON-ABBOTT BDC TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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
    241417 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 81026G2 08717648138140

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR