BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CORSAIR MICROCATHETER

    MDR report key: 2076413 · Received May 4, 2011

    Report

    Report Number
    3003775027-2011-00018
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQY
    PMA / PMN Number
    K083127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): USE AFTER DAMAGE. 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, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI (B)(4). THE DEVICE WAS RETURNED WITH THE PROXIMAL PORTION OF THE CORSAIR MICROCATHETER SHAFT CUT APPROXIMATELY 4 CM DISTAL FROM THE DISTAL END OF THE PROTECTOR, WHICH IS ATTACHED TO THE HUB CONNECTOR. THE SHAFT WAS BENT AT THE SECTION DISTAL TO THE DISTAL END OF THE PROTECTOR AND DEFORMED FOR APPROXIMATELY 15 MM IN LENGTH DUE TO TORTIONAL FORCE. UPON REMOVAL OF THE PROTECTOR, IT WAS FOUND THAT THE SHAFT WAS ALSO DEFORMED IN A WAVY SHAPE AT THE PROXIMAL END WHERE IT IS BONDED WITH THE HUB CONNECTOR. IT WAS REPORTED THAT THE CORSAIR STARTED TO UNRAVEL AT THIS AREA; HOWEVER, THE SHAFT WAS NOT UNRAVELLED, ALTHOUGH IT WAS DEFORMED. AFTER REMOVAL OF THE GUIDE WIRE FROM THE CORSAIR, THE SHAFT OF CORSAIR WAS HELD BENT AT THE SECTION DISTAL FROM THE PROTECTOR, ROTATIONAL MANIPULATION WAS EXCESSIVELY APPLIED TO THE HUB CONNECTOR RESULTING IN THE ACCUMULATION OF THE TORSIONAL FORCE TO THE BENT SECTION AND THE BONDED SECTION OF THE SHAFT, DEFORMATION OF THE SHAFT AND REDUCTION OF THE INNER LUMEN SIZE, AND RE-INSERTION DIFFICULTY OF THE RE-INSERTED GUIDE WIRE. THE WARNING SECTION OF INSTRUCTIONS FOR USE (IFU) DESCRIBES THE FOLLOWING: 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 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. ALWAYS HOLD THE CONNECTOR WITH ONE HAND AND TURN THE CATHETER CAREFULLY WHILE REGULARLY RELEASING THE ACCUMULATED TORSION OF THE CATHETER. WHEN RELEASING THE ACCUMULATED TORSION, BE SURE TO OPEN THE HEMOSTATIC VALVE ON THE Y-CONNECTOR. DO NOT TURN THE CATHETER IN THE SAME DIRECTION, EITHER CLOCKWISE OR COUNTERCLOCKWISE FOR MORE THAN 20 CONSECUTIVE TURNS. IF RESISTANCE IS FELT WHILE TURNING THE CATHETER, DO NOT PROCEED WITH FURTHER ROTATION EVEN IF 20 TURN LIMIT HAS NOT BEEN REACHED. 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 WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED WITH THIS PART AND LOT COMBINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE INVOLVING THE LEFT ANTERIOR DESCENDING ARTERY, LATERAL TO THE CIRCUMFLEX ARTERY, THAT WAS CHRONICALLY TOTALLY OCCLUDED, THE CORSAIR REACHED THE TREATMENT SITE; HOWEVER, WHEN THE GUIDE WIRE (TYPE UNKNOWN) WAS REMOVED IN ORDER TO CHANGE TO ANOTHER GUIDE WIRE (TYPE UNKNOWN), IT COULD NOT BE INSERTED INTO THE CORSAIR AT THE HUB. APPARENTLY, THE CORSAIR STARTED TO UNRAVEL AT THIS AREA. THE PHYSICIAN CHOSE TO CUT THE CORSAIR AT THIS AREA (1/2 INCH PAST THE HUB IN THE BRAIDED PORTION) IN ORDER TO BYPASS THE UNRAVELED AREA AND PROCEED WITH THE CASE. THE CASE WAS COMPLETED SUCCESSFULLY AND FOUR XIENCE V STENTS WERE IMPLANTED. THE PHYSICIAN STATED THAT THE CORSAIR WAS TWISTED A LOT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INJURY. 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 0701210051

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR