BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 7372025 · Received March 26, 2018

    Report

    Report Number
    2024168-2018-02192
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    March 16, 2018
    Report Date
    March 26, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648138072
    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. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION, SION BLUE. GUIDE CATHETER: HYPERION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD 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 AN 100% STENOSED, MILDLY TORTUOUS, AND HEAVILY CALCIFIED CONCENTRIC LESION IN THE DISTAL RIGHT CORONARY ARTERY. RESISTANCE WITH THE LESION WAS FELT WHEN ADVANCING A 1.50X6MM MINI TREK BALLOON DILATATION CATHETER (BDC) AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE BDC WAS REPLACED WITH ANOTHER SEMI-COMPLIANT BALLOON TO INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER TREATMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211746 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 70525G1 08717648138072

    Patients

    Seq Age Sex Outcome Treatment
    1