BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENKU DILATATION CATHETER

    MDR report key: 6528639 · Received April 27, 2017

    Report

    Report Number
    2024168-2017-03725
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 27, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    04544881152701
    PMA / PMN Number
    K103110
    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: RINATO, GUIDE CATHETER: HYPERION, STENT: XIENCE ALPINE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. ALTHOUGH THIS DEVICE IS NOT COMMERCIALLY AVAILABLE FOR SALE IN THE US, IT IS SIMILAR TO A DEVICE CURRENTLY MARKETED FOR SALE IN THE US. THE XIENCE ALPINE 2.75 X 23 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED, CONCENTRIC, AND DE NOVO FIRST DIAGONAL ARTERY THAT WAS 90% STENOSED. AN UNSPECIFIED XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WHEN PLAQUE SHIFT OCCURRED AT THE ENTRANCE OF THE FIRST DIAGONAL. A 1.5 X 12 MM RX TENKU WAS BEING USED TO DILATE THE VESSEL WHEN THE BALLOON RUPTURED ON THE FIRST INFLATION AFTER 10 SECONDS AT 6 ATMOSPHERES. A NON-ABBOTT BALLOON WAS SUCCESSFULLY USED TO 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
    309413 TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50209G1 04544881152701

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR