BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGALIA XS 1.0

    MDR report key: 18638181 · Received February 5, 2024

    Report

    Report Number
    3003775027-2024-00014
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    January 15, 2024
    Report Date
    February 5, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K163426
    Adverse Event
    Yes
    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. 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 REPORTED REGALIA XS 1.0 GUIDE WIRE WAS RETURNED FOR EVALUATION. THE POLYMER JACKET WAS FOUND PEELED OFF AT APPROXIMATELY 23-54MM FROM THE TIP, EXPOSING THE UNDERLYING COIL. SCRATCHES WERE OBSERVED ON THE POLYMER JACKET AT APPROXIMATELY 58MM AND 62 MM FROM THE TIP, WHICH WERE LIKELY CAUSED BY TORSION. MICROSCOPIC OBSERVATION OF THE SEGMENT WHERE THE POLYMER JACKET HAD BEEN PEELED OFF FOUND THAT THE DISTAL TORN END OF THE POLYMER JACKET WAS FLIPPED OVER DISTALLY FOR APPROXIMATELY 2MM. THE COIL SEGMENT WAS HELICAL DEFORMED. THE PROXIMAL TORN END OF THE POLYMER JACKET WAS STRETCHED BY TENSILE STRESS. 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 THE REGALIA XS 1.0 GUIDE WIRE MIGHT HAVE BEEN TORQUED WHILE THE WIRE TIP WAS TEMPORARILY CAUGHT DUE TO ANATOMICAL CONDITIONS. CONSEQUENTLY, THE POLYMER JACKET WAS SCRATCHED AND DAMAGED. FURTHER APPLIED TENSILE STRESS GENERATED WITH REMOVAL THEN MADE THE POLYMER JACKET STRETCH, TORN AND THEN PEEL OFF. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. GIVEN THE DAMAGE OBSERVED ON THE RETURNED GUIDE WIRE, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT SOME POLYMER JACKET FRAGMENT(S) 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. 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 THAT AN ENDOVASCULAR TREATMENT (EVT) WAS PERFORMED TO TREAT A MODERATELY CALCIFIED PERIPHERAL ARTERY DISEASE (PDA). WHEN AN ASAHI REGALIA XS 1.0 GUIDE WIRE WAS ADVANCED VIA ANTEGRADE IPSILATERAL APPROACH, THE GUIDE WIRE COULD NOT BE MANIPULATED AS INTENDED. ON CHECKING THE REGALIA XS 1.0 GUIDE WIRE, THE POLYMER JACKET WAS FOUND BURRED. A NEW REGALIA XS 1.0 GUIDE WIRE WAS USED TO RESUME THE PROCEDURE. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO SUCCESSFULLY REESTABLISH BLOOD FLOW. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS AND THE PATIENT WAS FINE WITHOUT PROBLEM AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558183 REGALIA XS 1.0 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 230706A01F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other