BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORSAIR PRO

    MDR report key: 18390044 · Received December 24, 2023

    Report

    Report Number
    3003775027-2023-00133
    Event Type
    Injury
    Date Received
    December 24, 2023
    Date of Event
    November 22, 2023
    Report Date
    July 22, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    PMA / PMN Number
    K171933
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** AS WE RECEIVED AN EMAIL TIME-STAMPED WEDNESDAY, (B)(6) 2024 3:23 AM AT OUR END FROM (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US THAT INFORMATION ABOUT THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A WAS INCORRECT. ALTHOUGH CORSAIR PRO IS CURRENTLY US MARKETED, THE SUBJECT MODEL IS SOLD ONLY OUTSIDE THE US. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT OF CORSAIR PRO IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NO ENTRY TO CSR135-26PR CATALOG # - FROM CSR135-26PR TO NO ENTRY G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. EMAIL - FROM [email protected] TO [email protected] H4: DEVICE MANUFACTURE DATE - FROM 16-8-2023 TO NO ENTRY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749. WHEN THE REPORTED PRODUCT WAS RETURNED TO THE MANUFACTURER, REPORTABLE MALFUNCTION WAS RECOGNIZED FOR THE FIRST TIME; THEREFORE, G3. DATE RECEIVED BY MANUFACTURER IS THE SAME AS THE DATE IN D9. RETURNED TO MANUFACTURER. THE REPORTED CORSAIR PRO MICROCATHETER AND ITS CONCOMITANT FIELDER XT-R GUIDE WIRE WERE RETURNED FOR INVESTIGATION. THE FIELDER XT-R GUIDE WIRE WAS FOUND INSERTED IN THE CORSAIR PRO MICROCATHETER, AND THE GUIDE WIRE COULD NOT BE WITHDRAWN FROM THE MICROCATHETER. MICROSCOPIC OBSERVATION OF THE TIP SEGMENT OF THE CORSAIR PRO MICROCATHETER FOUND CIRCUMFERENTIAL SCRATCHES ON THE DISTAL SEGMENT, WHICH WERE PROBABLY CAUSED BY CONTACT WITH CALCIUM. THE TIP AND POLYMER JACKET WERE FOUND PEELED BETWEEN THE TIP AND SHAFT. X-RAY OBSERVATION OF THE TIP SEGMENT FOUND THAT THE BRAIDS WERE DEFORMED AND THE CATHETER LUMEN WAS REDUCED IN SIZE. 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 TORSION GENERATED WITH CATHETER MANIPULATION WHILE THE TIP SEGMENT OF THE CORSAIR PRO MICROCATHETER WAS CAUGHT BY THE HEAVILY CALCIFIED LESION MOST LIKELY CONTRIBUTED TO DISARRANGEMENT OF THE BRAIDS, CAUSING THE MICROCATHETER AND THE FIELDER XT-R GUIDE WIRE TO GET STUCK TO EACH OTHER. THE TIP AND THE POLYMER JACKET WERE SCRATCHED AS THE TIP SEGMENT OF THE CORSAIR PRO MICROCATHETER WAS IN STRONG CONTACT WITH THE CALCIUM. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. ALTHOUGH THERE WERE REPORTEDLY NO ADVERSE PATIENT EFFECTS, IT WAS CONCLUDED THAT POTENTIALITY COULD NOT BE COMPLETELY RULED OUT THAT THE TIP AND POLYMER FRAGMENT MIGHT BE LEFT IN THE PATIENT AS DAMAGE OF THE RETURNED CORSAIR PRO MICROCATHETER WAS TOO SEVERE. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] DO NOT USE THIS MICROCATHETER IN ADVANCED CALCIFIED LESION. 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]: DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI CORSAIR PRO MICROCATHETER AND AN ASAHI FIELDER XT-R GUIDE WIRE WERE ADVANCED IN THE CHRONIC TOTAL OCCLUSION (CTO) LESION DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE HEAVILY CALCIFIED CTO LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX), SEGMENT #11 TO SEGMENT #13. WHEN AN ATTEMPT WAS MADE TO REMOVE THE FIELDER XT-R GUIDE WIRE, THE GUIDE WIRE GOT STUCK WITH THE CORSAIR PRO MICROCATHETER. THE TWO DEVICES WERE REMOVED TOGETHER. A NEW CORSAIR PRO MICROCATHETER AND A NEW FIELDER XT-R GUIDE WIRE WERE USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH REESTABLISHED BLOOD FLOW BY STENTING. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610572 CORSAIR PRO PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. CSR135-26PR 230727K05A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other