BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 2931957 · Received January 28, 2013

    Report

    Report Number
    2024168-2013-00443
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED KINK AND SHAFT SEPARATION WERE CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS 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. THE TENKU BALLOON DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN JAPAN BY ST. JUDE MEDICAL JAPAN COMPANY, LTD. 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 THE 3.25X12 MM NC TENKU BALLOON CATHETER WAS REMOVED OUT OF THE DISPENSER AND THE CATHETER WAS COILED/WOUND DUE TO THE LONG SHAFT; HOWEVER, DURING COILING OF THE DEVICE THE SHAFT BENT AND SEPARATED APPROXIMATELY 15 CM FROM THE HUB. NO SUBSTANTIAL FORCE WAS APPLIED TO THE SHAFT WHEN COILING THE BALLOON CATHETER. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38076 NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2081061

    Patients

    Seq Age Sex Outcome Treatment
    1