BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SION

    MDR report key: 18179457 · Received November 20, 2023

    Report

    Report Number
    3003775027-2023-00118
    Event Type
    Injury
    Date Received
    November 20, 2023
    Report Date
    July 19, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327130899
    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, (B)(6) 2024 1:27 AM AT OUR END FROM MR. (B)(6) , 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 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 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 TO ASAHI SION. D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NO ENTRY TO AH14R101SR. CATALOG # - FROM AH14R101SR TO NO ENTRY. G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE - FROM 19-6-2023 TO NO ENTRY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: TOYOFLEX CEBU CORPORATION, CEBU, PHILIPPINES, REGISTRATION NUMBER: 3016119728. EVALUATION OF THE AFFECTED SION GUIDE WIRE COULD NOT BE PERFORMED BECAUSE IT WAS DISCARDED BY THE USER FACILITY. THE CONCOMITANTLY USED BALLOON CATHETER WAS PROVIDED. EXPANSION LIQUID WAS FOUND REMAINED INSIDE THE BALLOON SEGMENT OF THE CONCOMITANT BALLOON CATHETER AND THE BALLOON WAS NOT WRAPPED SUFFICIENTLY. THE INNER TUBE OF THE BALLOON CATHETER WAS FOUND BUCKLED AND CRUSHED IN THE PROXIMAL SEGMENT OF THE BALLOON. 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 DEFORMATION OF THE INNER TUBE OF THE CONCOMITANT BALLOON CATHETER MIGHT HAVE CONTRIBUTED TO THE STUCK WITH THE SION GUIDE WIRE. TENSILE STRESS GENERATED WITH WIRE REMOVAL HAD LIKELY LED THE SION TO SEPARATE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. AS THE AFFECTED SION GUIDE WIRE WAS NOT RETURNED FOR EVALUATION, IT WAS UNABLE TO COMPLETELY RULE OUT THE POTENTIALITY THAT SOME WIRE FRAGMENTS MIGHT BE LEFT IN THE PATIENT ANATOMY. 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. [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI SION GUIDE WIRE WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR AN UNSPECIFIED MODERATELY CALCIFIED SEGMENT OF THE RIGHT CORONARY ARTERY (RCA). WHEN A NON-ASAHI BALLOON CATHETER WAS ADVANCED OVER THE SION, IT GOT STUCK ON THE SION. AFTER REMOVAL, THE SION WAS FOUND SEPARATED. IT WAS CONFIRMED THAT THERE WAS NO SEPARATED WIRE FRAGMENT IN THE PATIENT ANATOMY. THE PROCEDURE WAS THEN RESUMED AND SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW ACHIEVED BY STENTING. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046649 ASAHI SION PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AH14R101SR 230504A02G 04547327130899

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other