BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CORSAIR

    MDR report key: 6850885 · Received September 7, 2017

    Report

    Report Number
    3003775027-2017-00152
    Event Type
    Injury
    Date Received
    September 7, 2017
    Report Date
    September 8, 2017
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    PMA / PMN Number
    K083127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE DETERMINED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. INFORMATION REGARDING DATE OF OCCURRENCE AND USER FACILITY WAS NOT AVAILABLE. DEVICE INVESTIGATION COULD NOT BE CONDUCTED AS THE DEVICE WAS NOT RETURNED. LOT HISTORY REVIEW COULD NOT BE CONDUCTED AS THE LOT INFORMATION WAS UNAVAILABLE. AS IT WAS WRITTEN IN THE ARTICLE THAT THE CATHETER INADVERTENTLY JUMPED, MOVED FORWARD, AND PERFORATED THE COLLATERAL CHANNEL, IT WAS CONCLUDED THAT CAUSATION OF THE PERFORATION WAS RELATED TO DEVICE MANIPULATION TECHNIQUE OF THE PHYSICIAN. ALTHOUGH THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW COULD NOT BE CONDUCTED, SINCE ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. INSTRUCTIONS FOR USE STATES: - [WARNINGS] WHEN THIS MICROCATHETER IS PLACED IN VESSEL, ALWAYS MANIPULATE IT WITH CARE BY CONFIRMING THE POSITION OF DISTAL END OF MICROCATHETER UNDER FLUOROSCOPY. SURFACE OF THIS MICROCATHETER IS PROVIDED WITH HYDROPHILIC COATING FOR LUBRICITY, THIS MICROCATHETER MAY HAPPEN TO BE ADVANCED TOO FAR TOWARD PERIPHERY OVER THE TARGET AREA OF THE OPERATOR'S AIM. (THE BLOOD VESSEL AND/OR THE MICROCATHETER MAY BE DAMAGED.); - [WARNINGS] PARTICULAR ATTENTION SHOULD BE PAID WHEN INSERTING OR WITHDRAWING THIS MICROCATHETER INTO OR FROM STENOTIC AREAS AND/OR NARROWER VESSELS THAN THIS MICROCATHETER. (IF EXCESSIVE ABRASIVE FRICTION OCCURS, DAMAGE OR BREAKAGE OF THIS MICROCATHETER AND/OR VESSEL DAMAGE OR VESSEL PERFORATION MAY OCCUR.); AND, - [MALFUNCTIONS AND ADVERSE EVENTS] DAMAGE TO VESSEL INCLUDING VESSEL DISSECTION, VESSEL PERFORATION AND VESSEL RUPTURE.

    Description of Event or Problem · 1

    ACCORDING TO A CASE REPORT "THE BALLOON-MICROCATHETER TECHNIQUE FOR TREATMENT OF CORONARY ARTERY PERFORATIONS" POSTED ON THE CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 89:E75-E83 (2017), AN ASAHI MICROCATHETER WAS USED FOLLOWING ADVANCEMENT OF A 7 FR. GUIDE CATHETER AND AN ASAHI GUIDE WIRE IN A RETROGRADE PROCEDURE TO TREAT A CTO IN THE RCA OSTIUM WHERE BLOOD WAS SUPPLIED VIA AN EPICARDIAL COLLATERAL CHANNEL FROM THE LAD. WHEN THE CATHETER WAS ADVANCING THROUGH THE COLLATERAL CHANNEL OVER THE GUIDE WIRE, IT INADVERTENTLY JUMPED AND MOVED FORWARD, CAUSING A LARGE VESSEL PERFORATION IN THE COLLATERAL CHANNEL. A BALLOON WAS IMMEDIATELY DELIVERED TO OCCLUDE THE LAD VIA A PARALLEL WIRE AND THE CATHETER WAS EXCHANGED TO A NON-ASAHI CATHETER WHILE TRAPPING THE GUIDE WIRE. THE BALLOON WAS TEMPORARILY DEFLATED SO THAT THE EXCHANGED CATHETER WOULD BE ADVANCED AS CLOSE AS TO THE PERFORATION. A TIP INJECTION WAS MADE THROUGH THE EXCHANGED CATHETER TO SEE THE DEGREE OF EXTRAVASATION. FOUR DETACHABLE COILS WERE THEN DELIVERED THROUGH THE EXCHANGED CATHETER TO SEAL THE PERFORATION. PERICARDIOCENTESIS WAS NOT NECESSARY AND THE PATIENT WAS DISCHARGED THREE DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628650 ASAHI CORSAIR PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention