BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARAVEL

    MDR report key: 20575240 · Received October 30, 2024

    Report

    Report Number
    3003775027-2024-00115
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 31, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    0454732713941
    PMA / PMN Number
    K152447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. THIS EVENT WAS INFORMED FROM OUR DISTRIBUTOR TO OUR OVERSEAS BRANCH IN CHARGE OF THE SUBJECT MARKET ON AUGUST 30, 2024. DUE TO OUR ORGANIZATIONAL CHANGES, THE PERSON IN CHARGE AT THE SUBJECT BRANCH WAS TEMPORARILY UNSPECIFIED AT THAT TIME. THE EVENT WAS INFORMED FROM THE SUBJECT BRANCH TO OUR VIGILANCE SECTION ON OCTOBER 10, 2024. THE REPORTED CARAVEL MICROCATHETER WAS RETURNED FOR INVESTIGATION. THE RETURNED CARAVEL MICROCATHETER WAS FOUND CORRUGATED THROUGHOUT ITS LENGTH. DISARRANGED STRANDS WERE INTERMITTENTLY OBSERVED FOR APPROXIMATELY 400MM FROM THE CATHETER TIP. MICROSCOPIC OBSERVATION OF THE TIP SEGMENT PROXIMAL TO THE TORN END FOUND CIRCUMFERENTIAL CRACKS ON THE TIP SURFACE, INDICATING THAT THE DISTAL TIP POLYMER WAS STRETCHED AS TENSILE STRESS WAS APPLIED. THE TIP FRACTURE EDGE WAS FOUND WITH A TRACE OF DUCTILE FRACTURE AS WELL AS EXPOSED BRAIDS. THE INVESTIGATION FINDINGS INDICATED THAT THE CARAVEL MICROCATHETER WAS TORN OFF FOR APPROXIMATELY 2MM FROM ITS TIP END. 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 TENSION GENERATED WITH WITHDRAWAL ATTEMPTS MIGHT HAVE BEEN APPLIED TO THE SUBJECT CARAVEL MICROCATHETER WHILE ITS DISTAL SEGMENT WAS CAUGHT IN THE CALCIUM IN THE HEAVILY TORTUOUS AND HIGHLY STENOSED LESION. CONSEQUENTLY, THE TIP POLYMER WAS STRETCHED AND TORN OFF. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, IT WAS CONCLUDED THAT THE FRAGMENT LEFT IN THE PATIENT ANATOMY WAS A HEALTH HAZARD. CAPA: NO CAPA WILL BE TAKEN. THE 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.) DO NOT INSERT OR WITHDRAW THIS MICROCATHETER INTO OR THROUGH STENT STRUTS. [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 TORTUOUS, MODERATELY CALCIFIED, AND 90-99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ASAHI CARAVEL MICROCATEHTER WAS USED AS A SUPPORT WITH A RUN THROUGH NS EXTRA FLOPPY GUIDE WIRE (TERUMO) TO CROSS THE LESION. DURING CROSSING ATTEMPTS, THE TWO DEVICES GOT STUCK TO EACH OTHER. THE MICROCATHETER WAS EVENTUALLY PULLED OUT OF THE PATIENT ANATOMY; HOWEVER, THE DISTAL SEGMENT OF THE MICROCATHETER WAS FOUND LEFT IN THE D2 SEGMENT OF THE PATIENT ANATOMY UNDER X-RAY. THE PHYSICIAN DECIDED TO DEPLOY AN UNSPECIFIED DRUG-ELUTING STENT (DES) TO THE MID LAD AND COMPLETED THE PROCEDURE. IT WAS INFORMED THAT THERE WERE NO COMPLICATIONS OR UNCOMFORTABLY CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962290 CARAVEL PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. CSR135-19P 240430K321 0454732713941

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Disability