BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 3143564 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03470
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 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). CONCOMITANT PRODUCTS: GUIDE WIRE: JOKER. GUIDE CATH: AXESS PB3.5. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE MILDLY TORTUOUS, HEAVILY CALCIFIED AND CONCENTRIC LEFT ANTERIOR DESCENDING ARTERY, THE 3.0X15 NC TENKU BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE DEVICE WAS WITHDRAWN FROM THE ANATOMY AND THE PROCEDURE WAS CONTINUED USING A 3.0X12 NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245325 NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2080961

    Patients

    Seq Age Sex Outcome Treatment
    1