BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARAVEL

    MDR report key: 17667965 · Received September 1, 2023

    Report

    Report Number
    3003775027-2023-00081
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327108942
    PMA / PMN Number
    K152447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749 THE REPORTED CARAVEL MICROCATHETER WAS RETURNED FOR EVALUATION WITH THE SEPARATED CATHETER TIP. THE RETURNED CARAVEL WAS FOUND TORN AT APPROXIMATELY 1MM FROM THE TIP. TRACES OF DUCTILE TEARING BY TENSILE STRESS WERE OBSERVED ON THE TORN ENDS. A SLIT WAS FOUND ON THE SEPARATED CATHETER TIP, WHICH WAS LIKELY MADE BY A HARD AND SHARP-EDGED OBJECT FROM THE OUTSIDE INTO THE INSIDE OF THE TIP. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TENSILE STRESS GENERATED WITH REMOVAL HAD MOST LIKELY CONTRIBUTED TO THE SEPARATION OF THE CATHETER TIP. AS THE TIP WAS BEING CAUGHT AND RESTRICTED ITS MOVEMENT BY THE LESION, THE APPLIED TENSILE STRESS EXCEEDED THE PRODUCT DESIGN LIMIT, TEARING THE CATHETER TIP. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [CONTRAINDICATIONS] DO NOT USE THIS MICROCATHETER IN ADVANCED CALCIFIED LESION. [WARNINGS] IF ANY RESISTANCE OR SOMETHING ABNORMAL IS FELT WHEN OPERATING THIS MICROCATHETER, DO NOT CONTINUE THE MANIPULATION WHILE THE CAUSES ARE UNCLEAR. IF IT IS SUSPECTED THAT THIS MICROCATHETER IS NOT OPERATING CORRECTLY, AVOID EXCESSIVE MANIPULATIONS, AND CAREFULLY REMOVE THE ENTIRE CATHETER SYSTEM WHILE PAYING FULL ATTENTION TO AVOID COMPLICATIONS. (CONTINUING THE MANIPULATION WHILE THE CAUSE OF THE PROBLEM IS NOT IDENTIFIED MAY CAUSE DAMAGE TO THIS MICROCATHETER, AND DAMAGE THE BLOOD VESSEL.) [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE SEGMENT #6 OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ASAHI CARAVEL MICROCATHETER WAS USED WITH AN ASAHI SION BLACK GUIDE WIRE. WHEN THE PHYSICIAN TRIED TO REMOVE THE CARAVEL AS THE CATHETER WAS STUCK IN THE CALCIFIED LESION, THE CATHETER TIP WAS SEPARATED. A NON-ASAHI GUIDE EXTENSION CATHETER AND A NON-ASAHI BALLOON CATHETER WAS THEN INSERTED. THE BALLOON WAS THEN INFLATED TO PRESS AGAINST THE TIP FRAGMENT AND THE SEPARATED TIP WAS RETRIEVED INTO GUIDE EXTENSION CATHETER. THE DEVICE SYSTEM WAS THEN REMOVED AS A UNIT. THE PROCEDURE WAS THEN RESUMED AND WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW ACHIEVED BY STENTING. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262214 CARAVEL PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. NA 230328K14A 04547327108942

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention