BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 8367205 · Received February 25, 2019

    Report

    Report Number
    2024168-2019-01405
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    January 11, 2019
    Report Date
    February 25, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    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, GUIDE CATHETER: HYPERION 6FR JL3.5. THE NC TRAVELER IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S. 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 OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. 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 PERFORMED TO TREAT A DE NOVO, ECCENTRIC LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. FOLLOWING THE ADVANCEMENT OF A NON-ABBOTT GUIDE WIRE, A 2.50 X 15 MM NC TRAVELER RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. RESISTANCE WITH THE ANATOMY WAS ALSO MET ON REMOVAL OF THE BDC INDEPENDENTLY. A NON-ABBOTT BDC WAS USED 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
    159337 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 70929G1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR