BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 7004862 · Received November 6, 2017

    Report

    Report Number
    2024168-2017-08729
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 6, 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

    (B)(4). INTERNAL FILE NUMBER - (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 6FR. JR4, OPTICROSS. 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 TRAVELER DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. A 4.0 X 12 MM NC TRAVELER BALLOON CATHETER WAS INFLATED ONE TIME TO 14 ATMOSPHERES WHEN THE BALLOON RUPTURED. A NON-ABBOTT STENT WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782204 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 70509G1

    Patients

    Seq Age Sex Outcome Treatment
    1