BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SION BLACK

    MDR report key: 18098596 · Received November 9, 2023

    Report

    Report Number
    3003775027-2023-00114
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    October 23, 2023
    Report Date
    July 19, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327123492
    PMA / PMN Number
    K173277
    Adverse Event
    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 SATURDAY, JULY 6, 2024 1:27 AM AT OUR END FROM (B)(4) , MDR DATA SYSTEMS TEAM, TO INFORM US OF THE DISCREPANCIES IN THE DEVICE IDENTIFICATION FIELDS OF OUR SUBMITTED ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A WHEN COMPARED WITH THE INFORMATION IN THE GUDID. ALTHOUGH ASAHI SION BLACK 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 ASAHI SION BLACK IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D1: BRAND NAME - FROM SION BLACK TO ASAHI SION BLACK D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NO ENTRY TO AP14R010PR CATALOG # - FROM AP14R010PR TO NO ENTRY G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE - FROM 20-2-2023 TO NO ENTRY,

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS DISCARDED BY THE USER FACILITY. 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 FORCE MIGHT HAVE BEEN APPLIED TO THE VESSEL WALL WHEN THE CONCOMITANTLY USED CORSAIR PRO WAS ADVANCED OUTSIDE THE STENT AND INTO THE D1, CAUSING THE VESSEL PERFORATION. HOWEVER, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT THE SION BLACK MIGHT HAVE CAUSED OR CONTRIBUTED TO THE PERFORATION. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. [MALFUNCTION AND ADVERSE EFFECTS] ~ DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED STENOSIS IN THE SEGMENT #6 OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ASAHI SION BLACK GUIDE WIRE WAS DELIVERED TO THE FIRST DIAGONAL BRANCH (D1) TO PROTECT THE SIDE BRANCH. AFTER STENTING IN THE SEGMENT #6, THE D1 DISAPPEARED DUE TO PLAQUE SHIFT. TO REESTABLISH THE BLOOD FLOW IN THE D1, AN ASAHI CORSAIR PRO MICROCATHETER WAS ADVANCED OVER THE SION BLACK THAT WAS IN THE D1. WHEN THE CORSAIR PRO WAS DELIVERED TO THE D1 THROUGH THE OUTSIDE OF THE STENT, VESSEL PERFORATION WAS NOTED FROM THE D1. WHEN A NON-ASAHI EMBOLIZATION COIL WAS INSERTED INTO THE CORSAIR PRO AND PUSHED BY A NON-ASAHI PUSHER, THE COIL GOT STUCK NEAR THE TIP OF THE CORSAIR PRO. A NON-ASAHI COVERED STENT WAS DEPLOYED TO SEAL THE PERFORATION AND THE PROCEDURE WAS THEN COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. CORSAIR PRO: MFR REPORT #: 3003775027-2023-00113. SION BLACK: MFR REPORT #: 3003775027-2023-00114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103198 ASAHI SION BLACK PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AP14R010PR 230201A80A 04547327123492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention