BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 5005338 · Received August 14, 2015

    Report

    Report Number
    2024168-2015-04679
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 21, 2015
    Report Date
    August 14, 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: SION, SION BLUE; GUIDE CATHETER: PROFIT 6F AL 1. THE TENKU BALLOON DILATATION 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. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE REPORTED OPERATES DIFFERENTLY THAN EXPECTED COULD NOT BE TESTED AS IT WAS AN OBSERVATION. THE REPORTED RESISTANCE WITH THE GUIDING CATHETER DURING ADVANCEMENT AND REMOVAL COULD NOT BE TESTED DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. 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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR 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 CONCENTRIC DE NOVO LESION IN THE 75% STENOSED, MILDLY TORTUOUS, HEAVILY CALCIFIED, PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.5X15MM NC TENKU BALLOON DILATATION CATHETER (BDC) WAS FLUSHED AND PREPPED FOR USE OUTSIDE OF THE PATIENT ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. DURING INSERTION OF THE 3.5X15MM NC TENKU BDC INTO A Y-CONNECTOR, THE SHAFT OF THE BDC SAGGED WITHOUT DEFORMING. RESISTANCE WAS FELT DURING ADVANCEMENT WITH THE GUIDING CATHETER; THEREFORE, THE BDC WAS REMOVED AND RESISTANCE WAS FELT WITH THE GUIDING CATHETER DURING REMOVAL. THE 3.5X15MM NC TENKU BDC WAS REMOVED CAREFULLY, BUT THE SHAFT OF THE BDC SEPARATED OUTSIDE OF THE PATIENT ANATOMY WHEN IT WAS PULLED OUT OF THE Y-CONNECTOR. THE SEPARATED PORTION OF THE 3.5X15MM NC TENKU BDC WAS SIMPLY WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT INTERVENTION. A NON-ABBOTT BDC WAS USED TO SUCCESSFULLY DILATE THE LESION AND AN UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE LESION. THE PROCEDURE RESULTED IN A REDUCTION TO 20% STENOSIS. 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
    540113 NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50105G1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR