BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGALIA XS 1.0

    MDR report key: 17786904 · Received September 21, 2023

    Report

    Report Number
    3003775027-2023-00091
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 21, 2023
    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: (B)(4). THE REPORTED REGALIA XS 1.0 GUIDE WIRE WAS RETURNED FOR EVALUATION WITH THE SEPARATED TIP FRAGMENT. THE POLYMER JACKET OF THE RETURNED REGALIA XS 1.0 WAS FOUND TORN AT APPROXIMATELY 88MM DISTAL TO THE PROXIMAL SOLDER (SET AT 120MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE), EXPOSING THE FRACTURED OUTER COIL. THE CORE WAS FRACTURED AT APPROXIMATELY 95MM DISTAL TO THE PROXIMAL SOLDER. MICROSCOPIC OBSERVATION FOUND THAT THE CORE FRACTURE END WAS TWISTED AND HAD A FLAT FRACTURE SURFACE, INFERRING THAT ACCUMULATED TORSION HAD CONTRIBUTED TO THE CORE FRACTURE. TRACES OF SOLDER WAS OBSERVED ON THE CORE FRACTURE END. THE FRACTURE END OF THE OUTER COIL WAS TWISTED AND HAD A FLAT FRACTURE SURFACE, INDICATING THAT THE COIL FRACTURE WAS ATTRIBUTED TO TORSION GENERATED MOST LIKELY WHEN THE OUTER COIL WAS PULLED AND STRAIGHTENED. TRACES OF DUCTILE TEARING BY TENSILE STRESS WERE OBSERVED ON THE TORN END OF THE POLYMER JACKET. THE SEPARATED TIP FRAGMENT WAS ABOUT 32MM LONG. A KINK WAS OBSERVED AT THE PROXIMAL SEGMENT OF THE TIP FRAGMENT, WHICH WAS LIKELY CAUSED BY SNARING. AS SEEN ON THE PROXIMAL SIDE OF THE REGALIA XS 1.0, THE EXPOSED FRACTURE END OF THE OUTER COIL WAS TWISTED AND HAD A FLAT FRACTURE SURFACE. THE TORN END OF THE POLYMER JACKET WAS TWISTED AND HAD TRACES OF DUCTILE TEARING. THE BALL TIP WAS FOUND ATTACHED ON THE DISTAL END OF THE FRAGMENT. THE POLYMER JACKET OF THE TIP FRAGMENT WAS REMOVED AND THE OUTER COIL WAS UNWOUND TO EXPOSE THE CORE FRACTURE END ON THE DISTAL SIDE. THE CORE FRACTURE WAS FOUND LOCATED AT APPROXIMATELY 25MM FROM THE TIP. AS SEEN ON THE PROXIMAL SIDE, THE CORE FRACTURE END HAD A FLAT FRACTURE SURFACE AND TRACES OF SOLDER. INVESTIGATION OF THE RETURNED GUIDE WIRE SUGGESTED THAT THE CORE WAS FRACTURED AT THE DISTAL-MID SOLDER (SET AT 25MM FROM THE TIP), THE OUTER COIL WAS FRACTURED AND THE POLYMER JACKET WAS TORN AT APPROXIMATELY 32MM FROM THE TIP. MEASUREMENT OF THE RETURNED GUIDE WIRE AND RESEMBLANCE OF THE FRACTURE ENDS CONFIRMED THAT THE ENTIRE GUIDE WIRE WAS 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 AND THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH TORQUING MANIPULATION WAS ACCUMULATED ON THE TIP OF THE REGALIA XS 1.0 LIKELY WHEN THE TIP WAS TRAPPED BY THE LESION, FRACTURING THE CORE. AS FURTHER TENSILE STRESS GENERATED WITH REMOVAL OF THE GUIDE WIRE WAS APPLIED, THE OUTER COIL AND THE POLYMER JACKET WERE STRETCHED TO FRACTURE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. 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. ~ 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. ~ WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION. [MALFUNCTION AND ADVERSE EFFECTS]: ~ SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED 90-99% STENOSIS IN THE ANTERIOR TIBIAL ARTERY (ATA). WHEN AN ASAHI REGALIA XS 1.0 GUIDE WIRE WAS ADVANCED WITH THE SUPPORT OF A KANEKA MEDIX MIZUKI MICROCATHETER TO CROSS THE LESION, THE TIP OF THE REGALIA XS 1.0 GOT TRAPPED IN THE LESION AND WAS THEN SEPARATED. THE SEPARATED WIRE TIP WAS RETRIEVED USING A SNARE. THE GUIDE WIRE WAS THEN REPLACED TO RESUME THE PROCEDURE. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO SUCCESSFULLY REESTABLISH BLOOD FLOW. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS REPORTEDLY FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518708 REGALIA XS 1.0 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 230301A01F

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention