BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENKU DILATATION CATHETER

    MDR report key: 3900737 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04185
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    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). CONCOMITANT PRODUCTS: GUIDE WIRE: GAIA FIRST, SION BLUE, GUIDE CATHETER: LAUNCHER EBU3.5. THE TENKU 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. 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER BALLOON RUPTURES REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MID-RIGHT CORONARY ARTERY STENTING PROCEDURE, THE 1.20X6MM TENKU RX BALLOON DILATATION CATHETER MET RESISTANCE DURING ADVANCEMENT. ONCE AT THE CHRONICALLY OCCLUDED LESION, DURING THE SECOND INFLATION AT 14 ATMOSPHERE (ATM), THE BALLOON RUPTURED. SEVERAL NON-ABBOTT BALLOON CATHETERS WERE USED TO SUCCESSFULLY PRE-DILATE THE LESION, AND DILATATION WAS PERFORMED. A XIENCE XPEDITION STENT WAS THEN DEPLOYED, SUCCESSFULLY COMPLETING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377213 TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30501G1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR CONCOMITANT MEDICAL DEVICES