BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 2822879 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07015
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    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. INFLATION: MEDTRONIC EVEREST 30, GUIDE CATH: TERUMO RADIGUIDE JL3.5 6FR, STENT: NOBORI 3.5 X 24. (B)(4) - AGAINST RESISTANCE. THE RX NC TENKU BALLOON DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN (B)(4) 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT WAS REPORTED THAT THE NC TENKU WAS ADVANCED ALTHOUGH RESISTANCE WAS ENCOUNTERED; HOWEVER, IT SHOULD BE NOTED THAT THE WARNINGS SECTION OF THE RX TREK/MINI TREK CORONARY DILATATION CATHETER INSTRUCTIONS FOR USE STATES: IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. IF THE RESISTANCE CANNOT BE ELIMINATED, REMOVE THE INTERVENTIONAL DEVICES AS A UNIT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A NON-ABBOTT STENT WAS DEPLOYED WITHOUT PRE-DILATATION IN A MODERATELY CALCIFIED, 90% STENOSED, DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 4.0 X 15 NC TENKU RX BALLOON DILATATION CATHETER (BDC) WAS THEN ADVANCED INTO A NON-ABBOTT GUIDING CATHETER, THEN INTO THE NON-ABBOTT STENT WITH SLIGHT RESISTANCE FELT BETWEEN THE NC TENKU RX BALLOON AND THE STENT, TO PERFORM POST-DILATATION. THE NC TENKU RX BALLOON WAS SUCCESSFULLY INFLATED TWICE TO 16 ATMOSPHERES, USING A NON-ABBOTT INFLATION DEVICE. HOWEVER, DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT 16 ATMS. THE NC TENKU RX BDC WAS WITHDRAWN FROM THE ANATOMY WITH SLIGHT RESISTANCE NOTED DURING RETRACTION THROUGH THE NON-ABBOTT GUIDING CATHETER. POST-DILATATION WAS COMPLETED USING A NON-ABBOTT BDC WITHOUT RESISTANCE FELT DURING ADVANCEMENT AND RETRACTION OF THE BDC IN THE GUIDING CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1