BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI SION BLACK

    MDR report key: 24659553 · Received March 23, 2026

    Report

    Report Number
    3003775027-2026-00045
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327123495
    PMA / PMN Number
    K173277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: TOYOFLEX CEBU CORPORATION, CEBU, PHILIPPINES, REGISTRATION NUMBER: 3016119728. WHILE THE REPORTED SION BLUE GUIDE WIRE IS CURRENTLY MARKETED IN THE US UNDER THE MODEL NUMBER: APW14R010P, THE SUBJECT MODEL IS MARKETED SOME AREAS OUTSIDE THE US UNDER THE MODEL NUMBER: AP14R010PR. INVESTIGATION RESULT: THE REPORTED SION BLACK GUIDE WIRE WAS RETURNED FOR INVESTIGATION. THE RETURNED SION BLACK GUIDE WIRE WAS FOUND WITH ITS POLYMER JACKET (COATED ON THE WIRE SHAFT FOR 200MM FROM THE WIRE TIP) PEELED AND DISTALLY GATHERED FOR APPROXIMATELY 20MM, LIKELY CAUSED BY SEVERE ABRASION. THERE WAS NO SUCH DAMAGE AS SEPARATION OR DETACHMENT FOUND WITH THE POLYMER JACKET. MEASUREMENT AND OBSERVATION OF THE RETURNED SION BLACK GUIDE WIRE SUGGESTED THAT THE ENTIRE GUIDE WIRE WAS RETURNED WITH ITS POLYMER JACKET INTACT. LOT HISTORY RECORD REVIEW: LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. CONCLUSION: BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE POLYMER-COATED SHAFT SURFACE MIGHT HAVE BEEN SEVERELY ABRADED WHILE THE GUIDE WIRE HAD BEEN CURVED DUE TO ANATOMICAL AND VESSEL CONDITIONS. CONSEQUENTLY, THE POLYMER JACKET WAS DISTALLY GATHERED. ALTHOUGH IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTED TO THE PRODUCT QUALITY, IT WAS CONCLUDED THAT POSSIBILITY COULD NOT BE COMPLETELY RULED OUT THAT THE POLYMER FRAGMENT MIGHT BE LEFT IN SITU SHOULD THE SAME EVENT RECUR. CAPA: NO CAPA WILL BE TAKEN. THE 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]. ABRASION OF THE GUIDE WIRE COATING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI SION BLACK GUIDE WIRE WAS USED FOR STENT DEPLOYMENT TO A LESION IN THE SEVERELY ANGULATED RIGHT CORONARY ARTERY (RCA) DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). AFTER THE SION BLACK GUIDE WIRE SUCCESSFULLY CROSSED THE LESION, AN ATTEMPT WAS MADE TO ADVANCE AN UNSPECIFIED IVUS CATHETER ALONG THE GUIDE WIRE, WHEN SIGNIFICANT RESISTANCE WAS MET. WHEN THE GUIDE WIRE WAS REMOVED EX SITU, THE POLYMER JACKET OF THE GUIDE WIRE LOOKED PEELED. A DIFFERENT GUIDE WIRE WAS USED IN PLACE TO CONTINUE AND COMPLETE THE PROCEDURE WITHOUT ISSUE. IT WAS INFORMED THAT THERE WERE NO HEALTH ISSUES WITH THE PATIENT AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721090 ASAHI SION BLACK PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AP14R010PR 250703A14F 04547327123495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown