BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 3182336 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03857
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 27, 2013
    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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE TENKU BALLOON DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN (B)(4) BY (B)(4). THOUGH THIS DEVICE IS NOT COMMERCIALLY AVAILABLE FOR SALE IN THE US, IT IS SIMILAR TO A DEVICE CURRENTLY MARKETED FOR SALE IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RIGHT FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MILDLY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, DE NOVO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE 3.0 X 12 MM NC TENKU BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE TO 10 ATMOSPHERE (ATM) AND WOULD NOT INFLATE MORE. 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
    282003 NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2100361

    Patients

    Seq Age Sex Outcome Treatment
    1