BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CARAVEL

    MDR report key: 8182756 · Received December 19, 2018

    Report

    Report Number
    3003775027-2018-00220
    Event Type
    Injury
    Date Received
    December 19, 2018
    Report Date
    November 28, 2018
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    PMA / PMN Number
    K152447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ASAHI INTECC HAS DETERMINED THAT THE DATE RECORDED IN DATE OF THIS REPORT WAS ERRONEOUSLY REPORTED AS THE DATE THE REPORT WAS SUBMITTED RATHER THAN THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY. CORRECTIVE ACTION HAS BEEN TAKEN TO CLARIFY WHICH DATE SHOULD BE PROVIDED IN THE REPORT. THIS SUPPLEMENTAL REPORT IS INTENDED ONLY TO CORRECT THE DATE PROVIDED IN TO REFLECT THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE DETERMINED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS DISCARDED BY THE USER FACILITY. INVESTIGATION OF PRODUCTION RECORDS AND ADVERSE EVENTS DATA COULD NOT BE PERFORMED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALTHOUGH THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW COULD NOT BE PERFORMED, ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. WHEN AND HOW THE CARAVEL CONTRIBUTED TO HEMATOMA FORMATION COULD NOT BE IDENTIFIED; HOWEVER, POSSIBLE INVOLVEMENT OF THE CARAVEL COULD NOT BE COMPLETELY DENIED. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] THIS MICROCATHETER MUST ALWAYS BE OPERATED UNDER HIGH-RESOLUTION FLUOROSCOPIC GUIDANCE. PARTICULAR ATTENTION SHOULD BE PAID WHEN INSERTING OR WITHDRAWING THIS MICROCATHETER INTO OR THROUGH STENOTIC AREAS, AND NARROWER VESSELS THAN THE MICROCATHETER. (ABRASION MAY RESULT IN DAMAGE OF THIS MICROCATHETER. THIS MAY CAUSE VASCULAR INJURY AND PERFORATION.); AND, [MALFUNCTION AND ADVERSE EFFECTS] HEMORRHAGE OR HEMATOMA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS (75-90% OCCLUSION, STENT ORIGINALLY EMBEDDED IN (B)(6) 2014) IN THE RCA#3 TO #4PD. A SION BLUE GUIDE WIRE WAS ADVANCED WITH THE CARAVEL MICROCATHETER IN AN ATTEMPT TO CROSS THE LESION BUT FAILED. A NEW GUIDE WIRE (XT-R) WAS REPLACED AND REACHED THE PERIPHERAL 4PD. A SCORING BALLOON WAS INFLATED AT THE 4PD. THE SION BLUE WAS DELIVERED TO THE 4AV TO PERFORM POBA. KISSING BALLOON TECHNIQUE WITH SCORING BALLOON AND BALLOON WAS PERFORMED IN BOTH 4PD AND 4AV. AFTER DRUG COATED BALLOON WAS INFLATED IN THE 4AV, BALLOON DILATATION IN THE PROXIMAL #3 WAS PERFORMED WITH A SCORING BALLOON. THEN IVUS SHOWED A HEMATOMA-LIKE IMAGE AT THE OSTIUM OF #1 THROUGH THE PROXIMAL #3. XT-R IN THE 4PD WAS USED TO DELIVER A STENT TO REESTABLISH THE BLOOD FLOW AND TO COMPRESS THE HEMATOMA IN THE #1 THROUGH #3. AFTER STENT DEPLOYMENT IT WAS NOTED THAT THE SION BLUE WAS STUCK BETWEEN THE STENT AND THE VESSEL WALL. A CORSAIR PRO CATHETER WAS ADVANCED DISTAL TO THE STUCK SION BLUE TO SUCCESSFULLY PULL OUT THE GUIDE WIRE FROM THE ANATOMY. FINAL ANGIOGRAPH SHOWED GOOD STENT EXPANSION AND REESTABLISHED BLOOD FLOW AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED AS PREVIOUSLY PLANNED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018466 ASAHI CARAVEL PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention