BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SION BLUE

    MDR report key: 20364652 · Received October 3, 2024

    Report

    Report Number
    3003775027-2024-00109
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327098151
    PMA / PMN Number
    K163426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. (B)(6) VIETNAM, REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED. 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, LOT HISTORY REVIEW, AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT TENSION EXCEEDING THE PRODUCT DESIGN LIMIT GENERATED WITH WITHDRAWAL FOR REWIRING MIGHT HAVE BEEN APPLIED ON THE SUBJECT SION BLUE GUIDE WIRE WHILE THE DISTAL SEGMENT OF THE GUIDE WIRE WAS CAUGHT BETWEEN THE DEPLOYED STENT AND THE VESSEL WALL. CONSEQUENTLY, THE GUIDE WIRE WAS SEPARATED. ALTHOUGH IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTE TO THE PRODUCT QUALITY, REMOVAL ATTEMPTS OF THE FRAGMENT WITH SUCH DEVICE AS BALLOON CATHETER IS CONSIDERED AS AN ADDITIONAL TREATMENT AND A HEALTH HAZARD. IN ADDITION, THE WIRE FRAGMENT LEFT IN SITU AFTER STENT DEPLOYMENT IS ALSO CONSIDERED A HEALTH HAZARD. 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. ~ 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 AN ASAHI SION BLUE GUIDE WIRE WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A 90-99% OCCLUDED LESION IN THE LEFT MAIN TRUNK (LMT). AFTER AN UNSPECIFIED GUIDE WIRE CROSSED THE LESION, THE SUBJECT SION BLUE GUIDE WIRE WAS ADVANCED TO THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX). AFTER AN UNSPECIFIED DRUG ELUTING STENT (DES) WAS DEPLOYED TO THE TARGET LESION IN THE LMT TO LAD, AN ATTEMPT WAS MADE TO REWIRE THE SION BLUE GUIDE WIRE TO THE LCX, WHEN THE GUIDE WIRE LOOKED UNRAVELED. REMOVAL ATTEMPTS WERE MADE WITH AN UNSPECIFIED MICRO BALLOON CATHETER AND AN UNSPECIFIED BALLOON CATHETER, WITHOUT SUCCESS. THE DISTAL SEGMENT OF THE SION BLUE GUIDE WIRE WAS THEN FRACTURED, DETACHED, AND LEFT IN THE LMT. A DIFFERENT UNSPECIFIED DES WAS DEPLOYED AND THE WIRE FRAGMENT WAS PRESSED AGAINST THE VESSEL WALL. IT WAS INFORMED THAT THERE WERE NO ISSUES OCCURRED TO THE PATIENT, WHOSE CONDITIONS WERE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325658 ASAHI SION BLUE PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AHW14R004S 240315A44A 04547327098151

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention| S