BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 8140322 · Received December 6, 2018

    Report

    Report Number
    2024168-2018-09432
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 27, 2018
    Report Date
    December 6, 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 CATHETER. HYPERION 6F JR3.5. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO ANATOMICAL CONDITIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. 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 TO TREAT A DE NOVO, 90% STENOSED, MODERATELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY. THE BALLOON OF THE 2.75X08 MM NC TRAVELER BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 20 SECONDS. THE BDC WAS REPLACED WITH A NON-ABBOTT BDC TO CONTINUE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979333 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80402G1

    Patients

    Seq Age Sex Outcome Treatment
    1