BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SION

    MDR report key: 6850888 · Received September 7, 2017

    Report

    Report Number
    3003775027-2017-00154
    Event Type
    Injury
    Date Received
    September 7, 2017
    Report Date
    September 8, 2017
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    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 IN THE ARTICLE, THE CATHETER ON THE SUBJECT GUIDE WIRE 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. A POSSIBILITY COULD NOT BE RULED OUT THAT THE SUBJECT GUIDE WIRE MAY HAVE CONTRIBUTED TO THE PERFORATION. 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] USE THIS GUIDE WIRE CAREFULLY AS THE GUIDE WIRE MAY PENETRATE THE BLOOD VESSEL. OTHERWISE, IT MAY CAUSE ADVERSE EVENTS SUCH AS BLOOD VESSEL PERFORATION AND CORONARY ARTERY DISSECTION. THE HIGHER TORQUE PERFORMANCE, STIFFER DISTAL END, AND/OR HIGHER ADVANCEMENT FORCE MAY PRESENT A HIGHER RISK OF PERFORATION OR INJURY THAN IF USING A MORE FLEXIBLE GUIDE WIRE. THEREFORE, USE THE MOST FLEXIBLE GUIDE WIRE THAT WILL TREAT THE LESION (I.E., THE GUIDE WIRE WITH THE SMALLEST TIP LOAD THAT WILL TREAT THE LESION), AND TAKE DUE CARE TO MINIMIZE THE RISK OF PERFORATION OR OTHER DAMAGE TO BLOOD VESSELS.; AND, - [MALFUNCTIONS AND ADVERSE EVENTS] DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION.

    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
    628660 ASAHI SION PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention