BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 4932647 · Received July 22, 2015

    Report

    Report Number
    2024168-2015-04087
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    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: RINATO; GUIDE CATHETER: HYPERION 6F JL3.5; STENT: PROMUS PREMIER. THE 2.75X12MM NC TENKU RX BALLOON DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN JAPAN BY ST. JUDE MEDICAL JAPAN COMPANY, LTD. ALTHOUGH THIS DEVICE IS NOT COMMERCIALLY AVAILABLE FOR SALE IN THE US, IT IS SIMILAR TO A DEVICE CURRENTLY MARKETED FOR SALE IN THE U.S. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO CONCENTRIC LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH MILD TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS. AFTER A NON-ABBOTT STENT WAS IMPLANTED IN THE LESION, A 2.75X12MM NC TENKU BALLOON DILATATION CATHETER (BDC) WAS PREPPED FOR USE. THERE WAS NO RESISTANCE DURING REMOVAL OF THE STYLET OR PROTECTIVE SHEATH, THE DEVICE WAS SOAKED PRIOR TO USE AND AIR WAS ASPIRATED OUTSIDE THE ANATOMY. NO ISSUES OR LEAKS WERE NOTED DURING PREPARATION. THE 2.75X12MM NC TENKU BDC WAS ADVANCED FOR POST-DILATATION. HOWEVER WHEN THE BALLOON WAS INFLATED FOR THE FIRST TIME TO 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NEW 2.75X12MM NC TENKU BDC, RESULTING IN 0% STENOSIS IN THE LAD. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474919 NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50106G1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR CONCOMITANT MEDICAL DEVICES