BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAIA NEXT 2

    MDR report key: 15332316 · Received August 31, 2022

    Report

    Report Number
    3003775027-2022-00100
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    July 29, 2022
    Report Date
    September 1, 2022
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327138956
    PMA / PMN Number
    K192599
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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). DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS DISCARDED BY THE USER FACILITY. THE PROVIDED VIDEO SHOWED GAIA NEXT 2 WAS FUSED INSIDE CORSAIR PRO XS AND ABOUT 1CM OF THE TIP OF GAIA NEXT 2 WAS OUT OF THE TIP OF CORSAIR PRO XS. 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 REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT TORSION GENERATED DURING WIRE DELIVERY HAD LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY IN REMOVAL. THE APPLIED STRESS WOULD LOCALIZE AND EXCEED THE PRODUCT DESIGN LIMIT WHEN THE WIRE HAD TEMPORARILY RESTRICTED ITS MOVEMENT DUE TO ANATOMICAL CONDITIONS AND THUS THE OUTER COIL BECAME LOOSENED. BECAUSE OF THE LOOSENED COIL, THE SUBJECT GUIDE WIRES INTERFERED OR FUSED WITH THE CONCOMITANTLY-USED MICROCATHETERS. 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. [MALFUNCTION AND ADVERSE EFFECTS] REMOVAL DIFFICULTY OF GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIFFICULTY IN REMOVING GUIDE WIRE OCCURRED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS DOING REVERSE CART WITH AN ASAHI GAIA NEXT 2 GUIDE WIRE WITH A NON-ASAHI TURNPIKE LP MICROCATHETER INITIALLY AND WELL PROGRESSED TO DISTAL RCA, BUT THE WIRE WAS STUCK AT SOME POINT AND UNABLE TO ADVANCE FURTHER. HE STRUGGLED SOME TIME TO PULL OUT AND HAD TO WITHDRAW THEM TOGETHER. THE OPERATOR THOUGHT MAYBE AN ISSUE OF TURNPIKE LP. THEN INSERTED ANOTHER NEW GAIA NEXT 2 WITH CORSAIR PRO XS MICROCATHETER BUT THE SAME ISSUE HAPPENED JUST BEYOND LEFT MAIN WHICH UNABLE TO ADVANCE THE WIRE FURTHER AGAIN, AND HAD THE SAME FEEDBACK IN HIS HAND. AGAIN REMOVED THEM TOGETHER. HE TRIED TO SEPARATE THE WIRE FROM THE CORSAIR PRO XS 150 OUTSIDE THE PATIENT BUT FAILED. HE STOPPED THE CASE AT THAT POINT BECAUSE HE HAD TO RETRIEVE BOTH THE WIRE AND MICROCATHETER FROM THE CASE AND REWIRING IT MIGHT TAKE MORE TIME. THE CASE HAD GONE ON LONG ENOUGH THEREFORE HE STOPPED THE CASE. THE PATIENT WAS FINE WITHOUT ISSUE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2449084 GAIA NEXT 2 PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 220120A461 04547327138956

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other