BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 7112944 · Received December 13, 2017

    Report

    Report Number
    2024168-2017-09668
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 13, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION, SION BLUE; GUIDE CATH: HYPERION 6FR SPB3.5. 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 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, ECCENTRIC AND HEAVILY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY THAT WAS 90% STENOSED. AN ATTEMPT AT PRE-DILATATION WAS DONE WITH A 2.5 X 12 MM NC TRAVELER BALLOON CATHETER; HOWEVER, AFTER THE BALLOON WAS INFLATED AT 12 ATMOSPHERES (ATMS), IT RUPTURED AT 14 ATMOSPHERES (ATMS) DURING THE SECOND INFLATION. THEREFORE, THE DEVICE WAS REPLACED WITH A 3.0 X 12 MM NC TRAVELER AND A 3.0 X 20 MM UNSPECIFIED DRUG COATED BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891470 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 70807G1

    Patients

    Seq Age Sex Outcome Treatment
    1