BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 6265349 · Received January 19, 2017

    Report

    Report Number
    2024168-2017-00575
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    December 26, 2016
    Report Date
    January 31, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION, GUIDE CATHETER: HYPERION, STENT: XIENCE ALPINE 3.0X38MM. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE NC TRAVELER IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND 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 DURING A PROCEDURE OF THE MILDLY TORTUOUS, ECCENTRIC, MODERATELY CALCIFIED, DISTAL RIGHT CORONARY ARTERY (RCA), AFTER STENT IMPLANTATION, THE 3.5 X 20 MM NC TRAVELER BALLOON CATHETER WAS ADVANCED, BUT MET RESISTANCE WITH THE STENT. DURING INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERE (ATM). THE BALLOON WAS REMOVED AND A DIFFERENT 3.5 X 15 MM NC TRAVELER BALLOON WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46759 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50904G1

    Patients

    Seq Age Sex Outcome Treatment
    1