BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENKU DILATATION CATHETER

    MDR report key: 5746711 · Received June 23, 2016

    Report

    Report Number
    2024168-2016-04100
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 23, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    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). THE TENKU DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN (B)(4) BY ST. JUDE MEDICAL (B)(4) COMPANY, LTD. ALTHOUGH THIS DEVICE IS NOT COMMERCIALLY AVAILABLE FOR SALE IN THE US. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY APPEARS 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 FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT 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 MODERATELY TORTUOUS AND HEAVILY CALCIFIED, 99% STENOSED, DE NOVO, CONCENTRIC LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 1.20X6 MM TENKU RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE FOR PRE-DILATATION; HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 10 ATMOSPHERES (ATM)/15 SECONDS. A 2.0MM TENKU BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398381 TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50107G1

    Patients

    Seq Age Sex Outcome Treatment
    1