BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CORSAIR MICROCATHETER

    MDR report key: 1998287 · Received February 22, 2011

    Report

    Report Number
    3003775027-2011-00005
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 28, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQY
    PMA / PMN Number
    K083127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH, IT WAS INITIALLY REPORTED THE DEVICE WAS EXPECTED TO BE RETURNING, SUBSEQUENT INFORMATION INDICATES THE DEVICE WILL NOT BE RETURNED. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: WE PRESUME AND CONSIDER FROM THE PROVIDED INFORMATION THAT THE TIP OF THE CORSAIR CATHETER WAS TRAPPED BY THE HEAVILY CALCIFIED LESION, WHEN THE PULL-BACK MANIPULATION AND/OR ROTATIONAL TORQUE MANIPULATION WAS APPLIED, THE MANIPULATION FORCE WAS ACCUMULATED AND EXCEEDED THE PRODUCT DESIGN LIMIT, RESULTING THE TIP BREAKAGE. THE INSTRUCTIONS FOR USE (IFU) DESCRIBES IN THE SECTION OF CONTRAINDICATIONS AND PROHIBITION: 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 PROHIBITED USE TO HEAVILY CALCIFIED LESION. WARNING SECTION OF IFU DESCRIBES: 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. CONTINUING THE OPERATION WHILE THE CAUSE OF THE PROBLEM IS NOT IDENTIFIED MAY CAUSE DAMAGE TO OR RUPTURE OF THE CATHETER, AND DAMAGE THE BLOOD VESSEL. IN THE WORST CASE, LIFE-THREATENING ADVERSE EVENTS MAY OCCUR. WARNING FOR THE MANIPULATION AGAINST RESISTANCE IS DESCRIBED. AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS, RUPTURE IS DESCRIBED IN THE IFU. INVESTIGATION OF THE PRODUCTION RECORD REVEALED NO ANOMALY WITH THIS LOT. NO OTHER PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY, RESISTANCE WAS MET AND THE TIP OF THE CORSAIR MICROCATHETER SEPARATED FROM THE SHAFT. THE CATHETER WAS REMOVED FROM THE BODY. A STENT WAS USED TO EMBED THE SEPARATED TIP AGAINST THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 0200110011

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention BRIDGEPOINT MEDICAL GUIDE WIRE FOR STINGRAY