BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 7807678 · Received August 22, 2018

    Report

    Report Number
    2024168-2018-06530
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 22, 2018
    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 CATH: HYPERION 6F SAL 1.0. 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 DIFFICULTY APPEARS 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. THE NC TRAVELER IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN ECCENTRIC DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY WITH MILD TORTUOSITY, MODERATE CALCIFICATION AND 75% STENOSIS. A 3.50X15 MM NC TRAVELER RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO RESISTANCE FOR PRE-DILATATION. THE BALLOON RUPTURED ON ITS SECOND INFLATION TO 8 ATMOSPHERES FOR 30 SECONDS. THE BDC WAS REPLACED WITH A NON-ABBOTT BDC TO SUCCESSFULLY COMPLETE PRE-DILATATION. THERE WERE NO REPORTED 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
    648547 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 70918G1

    Patients

    Seq Age Sex Outcome Treatment
    1