BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SION BLUE

    MDR report key: 18001103 · Received October 25, 2023

    Report

    Report Number
    3003775027-2023-00108
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    September 29, 2023
    Report Date
    July 19, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327123624
    PMA / PMN Number
    K191464
    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 SATURDAY, JULY 6, 2024 1:27 AM AT OUR END FROM MR. JOHN HINES, 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 BLUE 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 BLUE 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 BLUE TO ASAHI SION BLUE D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NO ENTRY TO AH14R104SR, CATALOG # - FROM AH14R104SR TO NO ENTRY. G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE - FROM 05/23/2023 IF 230511A08F, 06/05/2023 IF 230517A01F TO NO ENTRY.

    Additional Manufacturer Narrative · 0

    THERE WERE TWO SUSPICIOUS LOTS FOR THE REPORTED GUIDE WIRE: 230511A08F OR 230517A01F. EXPIRATION DATE OF THE TWO SUSPICIOUS LOTS WAS THE SAME. H4 DEVICE MANUFACTURE DATE: 05/23/2023 IF 230511A08F, 06/05/2023 IF 230517A01F MANUFACTURING SITE: (B)(6), REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS DISCARDED BY THE USER FACILITY. LOT HISTORY REVIEW OF THE SUSPICIOUS TWO LOTS REVEALED NO ANOMALY RELATED TO THE REPORTED EVENT, AND NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM EITHER LOT. BASED ON THE OBTAINED INFORMATION, FINDING ON LOT HISTORY REVIEW, AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT TENSILE STRESS GENERATED WITH REMOVAL MIGHT HAVE BEEN LOCALLY APPLIED ON THE SION BLUE WHEN THE WIRE TIP WAS TRAPPED BY THE STENT STRUT. CONSEQUENTLY, THE GUIDE WIRE WAS FRACTURED. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. 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. ~ NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. ~ IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. ~ DO NOT PERFORM STENT PLACEMENT USING MORE THAN ONE GUIDE WIRE OR WIRE OPERATION THROUGH STENT STRUT. OTHERWISE, THE STENT MAY BE DAMAGED OR THE GUIDE WIRE MAY BREAK OR BREAK APART. [MALFUNCTION AND ADVERSE EFFECTS] ~ SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT AN IN-STENT CHRONIC TOTAL OCCLUSION (CTO) IN THE SEGMENT #3 OF THE RIGHT CORONARY ARTERY (RCA). AN ASAHI SION BLUE GUIDE WIRE WAS ADVANCED THROUGH THE STENT STRUTS. AFTER PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TWICE, THE SION BLUE GUIDE WIRE GOT FRACTURED AND WIRE FRAGMENT REMAINED IN THE PATIENT ANATOMY. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE WIRE FRAGMENT AND JUST LEAVE IT IN SITU. THE PROCEDURE WAS THEN TERMINATED. THE PHYSICIAN COMMENTED THAT THE WIRE FRACTURE WAS INFERRED TO BE ATTRIBUTED TO THE PROCEDURE, NOT PRODUCT QUALITY. THE PATIENT WAS FINE WITHOUT ANY PROBLEMS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433772 ASAHI SION BLUE PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AH14R104SR 230511A08F OR 230517A01F 04547327123624

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Disability