BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 3684869 · Received March 18, 2014

    Report

    Report Number
    2024168-2014-01601
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 4, 2014
    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). THE NC TENKU DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN (B)(6) 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. 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 FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, DE NOVO ECCENTRIC LESION IN THE DISTAL LEFT CIRCUMFLEX (CX). REPORTEDLY, AFTER THE STENT WAS IMPLANTED, THE 4.0 X 15MM NC TENKU BALLOON CATHETER WAS ADVANCED TO PERFORM THE KISSING BALLOON TECHNIQUE (KBT) FOR THE LEFT CIRCUMFLEX SIDE; HOWEVER, THE BALLOON RUPTURED DURING SECOND INFLATION AT 10 ATMOSPHERES. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL OF THE DEVICE. THE KBT WAS PERFORMED WITH ANOTHER BALLOON CATHETER. 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
    158795 NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2081061

    Patients

    Seq Age Sex Outcome Treatment
    1