BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 5258665 · Received December 1, 2015

    Report

    Report Number
    2024168-2015-07186
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    November 8, 2015
    Report Date
    December 1, 2015
    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). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE, SION. GUIDE CATH: HYPERION SL35. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 REPORTED FROM THIS LOT. 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 US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, CONCENTRIC, HEAVILY CALCIFIED, 90% STENOSED, DE NOVO, MID, LEFT ANTERIOR DESCENDING (LAD) ARTERY THE 2.25 X 12 MM NC TRAVELER BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCING IN THE VESSEL AND WAS USED FOR PRE-DILATATION; HOWEVER, DURING THE FIRST INFLATION AT 18 ATMOSPHERES THE BALLOON RUPTURED. THE BDC WAS REMOVED AND A NON-ABBOTT BDC WAS USED TO COMPLETE THE PRE-DILATATION FOLLOWED BY SUCCESSFUL NON-ABBOTT STENT IMPLANTATION. 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
    787841 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40805G1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR