BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI SION BLUE

    MDR report key: 19858203 · Received July 29, 2024

    Report

    Report Number
    3003775027-2024-00071
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 30, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K191464
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: (B)(4). WHEN THE REPORTED PRODUCT WAS RETURNED TO THE MANUFACTURER, REPORTABLE MALFUNCTION WAS RECOGNIZED FOR THE FIRST TIME; THEREFORE, G3. DATE RECEIVED BY MANUFACTURER IS THE SAME AS THE DATE IN D9. RETURNED TO MANUFACTURER. THE RETURNED SION BLUE GUIDE WIRE WAS FOUND BENT AT APPROXIMATELY 4MM FROM THE TIP. THE COIL PITCH WAS FOUND WIDENED AT APPROXIMATELY 28-35MM FROM THE TIP. AT APPROXIMATELY 28MM FROM THE TIP, THE DISTAL SEGMENT OF THE CORE WIRE WAS OBSERVED, WHICH WAS PRESSED FOR THE PURPOSE OF CONNECTING TO THE TIP SOLDER. FRACTURE END OF THE CORE WIRE WAS OBSERVED AT APPROXIMATELY 53MM FROM THE TIP. THE COIL WAS FOUND ELONGATED FROM THE PROXIMAL SOLDER FOR APPROXIMATELY 700MM. AT APPROXIMATELY 170MM DISTAL TO THE PROXIMAL SOLDER, FRACTURE END OF THE CORE WIRE WAS OBSERVED. MICROSCOPIC OBSERVATION FOUND THAT EACH FRACTURE END OF THE CORE WIRE WAS NECKED BY TENSILE STRESS. INVESTIGATION OF THE RETURNED GUIDE WIRE SUGGESTED THAT THE CORE WIRE WAS FRACTURED AT APPROXIMATELY 25MM FROM THE TIP AND THE DISTAL SEGMENT OF THE CORE WIRE WAS DETACHED FROM THE TIP SOLDER. 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 INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TENSILE STRESS MIGHT HAVE BEEN LOCALLY APPLIED ON THE SION BLUE GUIDE WIRE WHILE THE WIRE TIP WAS TEMPORARILY TRAPPED DURING WIRE MANIPULATION DUE TO VESSEL TORTUOSITY OR THE HEAVILY CALCIFIED LESION. CONSEQUENTLY, THE COIL AND THE CORE WIRE WERE STRETCHED, WIDENING THE COIL PITCH AND FRACTURING THE CORE WIRE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. AS CORE WIRE FRACTURE WAS OBSERVED ON THE RETURNED GUIDE WIRE AND A POSSIBILITY COULD NOT BE COMPLETELY RULED OUT THAT SOME WIRE FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT ANATOMY IF IT WERE TO RECUR, THIS EVENT WAS DETERMINED TO BE REPORTABLE. 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 VESSEL 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] BREAKAGE OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2024 THAT AN ASAHI SION BLUE GUIDE WIRE WAS DAMAGED ON JUNE 5. ADDITIONAL INFORMATION OBTAINED ON JUNE 14, 2024 INDICATED THAT THE SION BLUE GUIDE WIRE WAS USED DURING AN ANGIOPLASTY FOR A HEAVILY CALCIFIED CORONARY ARTERY. WHEN AN ATTEMPT WAS MADE TO REMOVE THE SION BLUE GUIDE WIRE AS THE PROCEDURE BECAME COMPLICATED, THE WIRE TIP WAS DAMAGED AND WIRE REMOVAL WAS DIFFICULT. THE PROCEDURE WAS CONTINUED WITH A NEW SION BLUE GUIDE WIRE AND WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW. IT WAS INFORMED THAT THE PATIENT WAS FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE. WHEN THE REPORTED SION BLUE GUIDE WIRE WAS RETURNED ON JULY 17, 2024, CORE WIRE FRACTURE WAS OBSERVED ON THE RETURNED GUIDE WIRE; THEREFORE, THIS EVENT WAS DETERMINED TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243912 ASAHI SION BLUE PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AHW14R104J 240126A181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown