BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARAVEL MC

    MDR report key: 20045308 · Received August 23, 2024

    Report

    Report Number
    3003775027-2024-00085
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 23, 2024
    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. ALTHOUGH CARAVEL IS CURRENTLY US MARKETED, THE SUBJECT MODEL IS SOLD OUTSIDE THE US UNDER THE BRAND NAME CARAVEL MC. THE DETACHED CATHETER TIP WITH A LENGTH OF APPROXIMATELY 2MM WAS RETURNED FOR EVALUATION WHILE THE REST OF THE CATHETER WAS NOT RETURNED. MICROSCOPIC OBSERVATION OF THE CATHETER FRAGMENT FOUND SCRATCHES OF THE POLYMER ON THE SURFACE. CIRCUMFERENTIAL CRACKS WERE OBSERVED ON THE TORN END, WHICH ARE TRACES OF DUCTILE TEARING OF TIP POLYMER DUE TO TENSILE STRESS. 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 THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE TIP OF THE CARAVEL MC MICROCATHETER MIGHT HAVE BEEN TEMPORARILY CAUGHT BY THE LESION DURING REMOVAL. CONSEQUENTLY, THE CATHETER TIP WAS SCRATCHED AND TENSILE STRESS GENERATED WITH REMOVAL ACCUMULATED ON THE SUBJECT SEGMENT, TEARING THE CATHETER TIP. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. AS THE CARAVEL MC MICROCATHETER WAS NOT RETURNED EXCEPT THE DETACHED CATHETER TIP, IT WAS UNABLE TO COMPLETELY RULE OUT THE POTENTIALITY THAT SOME CATHETER FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [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.) ~ 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.) [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 75-90% STENOSIS IN THE SEGMENT #6 OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ASAHI CARAVEL MC MICROCATHETER CROSSED THE LESION ALTHOUGH SOME RESISTANCE WAS MET DURING ADVANCEMENT. AFTER REMOVAL OF THE CARAVEL MC MICROCATHETER, DETACHED CATHETER TIP WAS NOTED IN THE PROXIMAL #6. THE DETACHED CATHETER TIP WAS REMOVED TOGETHER WITH THE DEVICE SYSTEM. THE DEVICES WERE THEN REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW. THE PATIENT WAS REPORTEDLY FINE WITHOUT ANY ISSUES WHICH COULD BE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528234 CARAVEL MC PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. CRV135-19M 240129K09A 04547327108942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other