BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI REGALIA XS 1.0

    MDR report key: 7547283 · Received May 27, 2018

    Report

    Report Number
    3003775027-2018-00101
    Event Type
    Injury
    Date Received
    May 27, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 10, 2018
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327058186
    PMA / PMN Number
    K083146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ASAHI INTECC HAS DETERMINED THAT THE DATE RECORDED IN BLOCK B4 "DATE OF THIS REPORT" WAS ERRONEOUSLY REPORTED AS THE DATE THE REPORT WAS SUBMITTED RATHER THAN THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY. CORRECTIVE ACTION HAS BEEN TAKEN TO CLARIFY WHICH DATE SHOULD BE PROVIDED IN THE REPORT. THIS SUPPLEMENTAL REPORT IS INTENDED ONLY TO CORRECT THE DATE PROVIDED IN BLOCK B4 TO REFLECT THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. (B)(4). THE RETURNED GUIDE WIRE WAS FOUND FRACTURED DISTAL TO THE MIDDLE SOLDER WHICH IS DESIGNED TO BE AT 25MM FROM THE WIRE TIP. AT THE FRACTURE SITE, THE POLYMER JACKET WAS TORN OFF AND THE CORE WIRE AND THE COIL WIRE UNDERNEATH WERE EXPOSED. PROXIMAL TO THE WIRE FRACTURE SITE, THE GUIDE WIRE WAS FOUND TWISTED AND DEFORMED HELICALLY DUE TO ACCUMULATED TORSION. SEM (SCANNING ELECTRON MICROSCOPE) WAS USED TO OBSERVE EACH FRACTURE SURFACE. A TRACE OF FRACTURE DUE TO ACCUMULATED TWISTING STRESS WAS OBSERVED ON THE COIL WIRE FRACTURE. THE CORE WIRE FRACTURE SURFACE WAS FLAT AND OBSERVED DIMPLES WITH ANNUAL-RING LIKE PATTERN, SUGGESTING TORSION WAS ACCUMULATED WHEN IT BECAME FRACTURED. THE SEPARATED TIP FRAGMENT WAS NOT RETURNED. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS CONCLUDED THAT ACCUMULATED TORSION AND STRESS ASSOCIATED WITH PUSHING-PULLING WIRE MANIPULATION THAT EXCEEDED THE PRODUCT DESIGN LIMIT WAS INADVERTENTLY APPLIED WHILE THE WIRE TIP WAS BEING TRAPPED BY THE OCCLUSION, CAUSING THE GUIDE WIRE TO BECOME FRACTURED. THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. 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. 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; [WARNINGS] WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720°) IN THE SAME DIRECTION; AND, [MALFUNCTION AND ADVERSE EFFECTS] DAMAGE (KINK, BEND, BREAK APART).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF AN ASAHI GUIDE WIRE BECAME SEPARATED DURING A PPI TO TREAT A MODERATELY CALCIFIED TOTAL OCCLUSION IN THE RIGHT POSTERIOR TIBIAL ARTERY. THE GUIDE WIRE WAS ADVANCED FOLLOWED BY A NON-ASAHI MICROCATHETER. TO DO TIP INJECTION, THE GUIDE WIRE WAS LEFT IN THE MIDDLE OF THE OCCLUSION AND THE MICROCATHETER WAS EXCHANGED. WHEN THE GUIDE WIRE WAS PULLED BACK, THE TIP SEGMENT BECAME SEPARATED. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE TIP FRAGMENT. THE GUIDE WIRE WAS REPLACED AND POBA WAS PERFORMED. THE PPI WAS COMPLETED WITH SUCCESSFULLY REESTABLISHED BLOOD FLOW. THE PATIENT WAS REPORTEDLY FINE WITHOUT PROBLEM AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389558 ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 171226A21A 04547327058186

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention