BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CARAVEL

    MDR report key: 7632874 · Received June 25, 2018

    Report

    Report Number
    3003775027-2018-00122
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    June 5, 2018
    Report Date
    June 7, 2018
    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

    Narratives

    Additional Manufacturer Narrative · 0

    ASAHI INTECC HAS DETERMINED THAT THE DATE RECORDED IN BLOCK B4 "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 BLOCK B4 TO REFLECT THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUBJECT MICROCATHETER AND THE CONCOMITANT GUIDE WIRE WERE RETURNED FOR EVALUATION. THE BROKEN TIP OF THE RETURNED CATHETER WAS TWISTED. DISTAL SHAFT WAS ALSO FOUND TWISTED FOR APPROXIMATELY 9 MM. ON THE TIP SURFACE, SCRATCHES POSSIBLY MADE BY CONTACT WITH HARD OBJECT WERE FOUND. THE BROKEN TIP END SHOWED A TRACE OF DUCTILE FRACTURE DUE TO TWISTING STRESS. BRAIDS UNDERNEATH THE TOP POLYMER LAYER WERE PARTIALLY EXPOSED. THE RETURNED GUIDE WIRE WAS DEFORMED IN C-CURVE. THE SEPARATED TIP SAT ON THE WIRE APPROXIMATELY 180 MM FROM THE WIRE TIP. MICROSCOPIC OBSERVATION FOUND MULTIPLE OBLIQUE SCRATCHES ON THE TIP SURFACE. THE SEPARATED TIP WAS SEVERELY TWISTED AND THE TIP END WITH MULTIPLE LACERATIONS WAS DRUG INTO THE TIP LUMEN. AS SEEN ON THE PROXIMAL SIDE, THE DISTAL BROKEN END OF THE TIP SHOWED A TRACE OF DUCTILE FRACTURE BY TWISTING STRESS. THE ABOVE FINDINGS SUGGESTED THAT THE TIP BROKE AT APPROXIMATELY 2 MM PROXIMAL TO THE TIP END WHERE CROSSED THE BORDER BETWEEN THE POLYMER-ONLY SEGMENT AND POLYMER-AND-BRAIDS SEGMENT. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS CONCLUDED THAT TIP SEPARATION WAS ATTRIBUTED TO TORSION EXCEEDING THE PRODUCT'S DESIGN LIMIT THAT WAS INADVERTENTLY APPLIED ON THE MICROCATHETER WHILE THE CATHETER TIP WAS BEING TRAPPED BY THE HEAVILY CALCIFIED CTO. THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. ALTHOUGH NO ADVERSE PATIENT EFFECT WAS REPORTED, THE TIP DAMAGE WAS TOO SEVERE TO COMPLETELY EXCLUDE A POSSIBILITY THAT TIP FRAGMENT(S) MIGHT BE LEFT IN THE ANATOMY. THE CONCOMITANT GUIDE WIRE HAD NO SIGNIFICANT DAMAGE, AND THEREFORE, DID NOT DIRECTLY CONTRIBUTE TO TIP SEPARATION. INSTRUCTIONS FOR USE (IFU) STATES THAT: [CONTRAINDICATIONS] DO NOT USE THIS MICROCATHETER IN ADVANCED CALCIFIED LESION; [WARNINGS] DO NOT ROTATE THIS MICROCATHETER IN ANY SITUATION. (ROTATING THIS MICROCATHETER MAY CAUSE DAMAGE TO THE MICROCATHETER, AND MAY ALSO DAMAGE THE BLOOD VESSEL.); [WARNINGS] DO NOT INSERT OR WITHDRAW THIS MICROCATHETER INTO OR THROUGH STENT STRUTS; [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.); AND, [MALFUNCTIONS] SEPARATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF AN ASAHI MICROCATHETER BECAME SEPARATED DURING A PCI TO TREAT A HEAVILY CALCIFIED 90-99% STENOSIS IN THE LAD. A 0.014 INCH ASAHI GUIDE WIRE WAS USED WITH THE MICROCATHETER. DURING WIRE MANIPULATION, THE PHYSICIAN FELT SOMETHING WRONG WITH THE WIRE AND THEN REMOVED TOGETHER WITH THE MICROCATHETER WHEN THE SEPARATED CATHETER TIP WAS FOUND ON THE REMOVED GUIDE WIRE. A NEW GUIDE WIRE WAS REPLACED TO RESUME THE PCI. THE PCI WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW BY STENTING. THE PHYSICIAN COMMENTED THAT TIP SEPARATION WAS ATTRIBUTED TO TORSION THAT HE APPLIED DURING MANIPULATION. THE PATIENT WAS DISCHARGED WITHOUT ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478004 ASAHI CARAVEL PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. NA 180208K05A 04547327108942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other