BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CORSAIR MICROCATHETER

    MDR report key: 2073066 · Received April 29, 2011

    Report

    Report Number
    3003775027-2011-00016
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQY
    PMA / PMN Number
    K083127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. DEVICE INVESTIGATION COULD NOT BE CONDUCTED. WE PRESUME AND CONSIDER FROM THE PROVIDED INFORMATION THAT THE TIP OF THE CORSAIR CATHETER WAS PROLAPSED AND/OR DEFORMED DUE TO THE FORCE EXCEEDING THE DESIGN OF THE PRODUCT LIMIT BY THE HEAVILY CALCIFIED CTO LESION, SO THAT THE GUIDE WIRE INSERTED IN THE CORSAIR MAY BE STUCK WITH THE CATHETER. THE INSTRUCTIONS FOR USE (IFU) STATES: LIFE-THREATENING EVENTS MAY OCCUR, DO NOT USE IN ADVANCED CALCIFIED LESIONS. THE REPORTED EVENT IS CONSIDERED TO HAVE OCCURRED BY USING THE DEVICE AGAINST THIS DESCRIPTION OF PROHIBITING USE IN HEAVILY CALCIFIED LESIONS. THE WARNING SECTION OF THE IFU STATES: ALWAYS ADVANCE THE GUIDE WIRE AHEAD OF THE MICROCATHETER, BEFORE ATTEMPTING ANY MANIPULATION OF THE MICROCATHETER (IF THE GUIDE WIRE IS NOT ADVANCED AHEAD OF THE MICROCATHETER, THE BLOOD VESSEL MAY BE DAMAGED OR PERFORATED OR THE MICROCATHETER MAY BE DAMAGED.) IF ANY RESISTANCE OR SOMETHING ABNORMAL IS FELT WHEN OPERATING THIS PRODUCT, DO NOT CONTINUE THE OPERATION WHILE THE CAUSES ARE UNCLEAR. IF IT IS SUSPECTED THAT THE PRODUCT IS NOT OPERATING CORRECTLY, AVOID EXCESSIVE MANIPULATIONS, AND CAREFULLY REMOVE THE ENTIRE CATHETER SYSTEM WHILE PAYING FULL ATTENTION TO AVOID COMPLICATIONS. AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS, REMOVAL DIFFICULTY, IS DESCRIBED IN THE IFU. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE, VIPER, WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED WITH THIS PART AND LOT COMBINATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION, RETROGRADE ACCESS WAS OBTAINED THROUGH THE LEFT ANTERIOR DESCENDING ARTERY USING A NON-ABBOTT GUIDE WIRE AND A CORSAIR MICROCATHETER. THE NON-ABBOTT GUIDE WIRE AND THE MICROCATHETER WERE SUCCESSFULLY ADVANCED TO THE TARGET LESION. AN UNSPECIFIED NUMBER OF XIENCE STENT SYSTEMS WERE SUCCESSFULLY ADVANCED VIA ANTEGRADE APPROACH FROM THE RIGHT CORONARY ARTERY AND THE STENTS WERE DEPLOYED SUCCESSFULLY. AT THE CONCLUSION OF THE PROCEDURE, THE MICROCATHETER TIP PROLAPSED AND THE GUIDE WIRE BECAME STUCK IN THE MICROCATHETER. BOTH DEVICES WERE REMOVED VERY SLOWLY AS A SINGLE UNIT FROM THE ANATOMY AND THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI CORSAIR MICROCATHETER SUPPORT CATHETER DQY AV-ASAHI 0700616161

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR GUIDE WIRE: CSI VIPER