BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 6258455 · Received January 17, 2017

    Report

    Report Number
    2024168-2017-00527
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    January 4, 2017
    Report Date
    January 17, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648196386
    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 BLUE, RUNTHROUGH. GUIDE CATH: HYPERION JR40. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THERE WAS NO LEAK NOTED DURING PREPARATION PRIOR TO USE, WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. 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. 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 THE PROCEDURE WAS TO TREAT A 99% STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED CONCENTRIC DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.0 X 12 MM NC TRAVELER BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS FELT WITH THE ANATOMY. THE BALLOON RUPTURED DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REPLACED WITH A NON-ABBOTT BDC AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER STENT IMPLANTATION. 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
    42309 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 51006G1 08717648196386

    Patients

    Seq Age Sex Outcome Treatment
    1