BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIUS MONGO

    MDR report key: 16842582 · Received May 1, 2023

    Report

    Report Number
    3003775027-2023-00047
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 26, 2023
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327123693
    PMA / PMN Number
    K180784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 WAS UPDATED ACCORDING TO ADDITIONAL CASE INFORMATION RECEIVED ON MAY 10, 2023.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS DISCARDED BY THE USER FACILITY. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. LOT HISTORY RECORDS REVIEW FOUND NO ANOMALY. BASED ON THE PROVIDED INFORMATION AND REFERRING TO KNOWN SLIMIER EVENTS, IT WAS PRESUMED THAT STRESS GENERATED WITH WIRE MANIPULATION IN ATTEMPTS TO CROSS HAD LIKELY CONTRIBUTED TO REPORTED TIP SEPARATION OF THE GLADIUS MG14 GUIDE WIRE. THE APPLIED STRESS WOULD ACCUMULATE AND THEREFORE EXCEED THE PRODUCT DESIGN LIMIT WHEN THE TIP WAS BEING CAUGHT AND RESTRICTED ITS MOVEMENT LIKELY BY THE LESION. 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] SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF AN ASAHI GLADIUS MG14 GUIDE WIRE HAD DETACHED DURING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT A NON-CALCIFIED OCCLUSION IN THE PROXIMAL RIGHT CORONARY ARTERY. DURING THE PROCEDURE, LOSS OF A 1 CM PIECE OF THE TIP OF THE GUIDEWIRE IN THE RIGHT CORONARY PROXIMAL WAS NOTED. THE GUIDE WIRE WAS USED SUBINTIMALLY BY KNUCKLE WIRE TECHNIQUE WITHOUT ANY PARTICULAR MISHANDLING BY THE OPERATOR. THE PIECE OF THE GUIDE WIRE WAS NOT RETRIEVED AND LEFT IN THE PATIENT'S CORONARY ARTERY. ANOTHER PCI IS PLANNED TO BE PERFORMED IN A MONTH TO STENT THE REMAINING PIECE OF THE GUIDE WIRE (NOT YET CONDUCTED AS OF ON (B)(6) 2023). THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT OUTCOME AFTER THE PROCEDURE WAS FINE AND THE PATIENT WAS DISCHARGED HOME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF AN ASAHI GLADIUS MG14 GUIDE WIRE HADE DETACHED DURING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT AN UNSPECIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. DURING THE PROCEDURE, LOSS OF A 1 CM PIECE OF THE TIP OF THE GUIDEWIRE IN THE RIGHT CORONARY PROXIMAL WAS NOTED. THE GUIDE WIRE WAS USED WITHOUT ANY PARTICULAR MISHANDLING BY THE OPERATOR. THE PIECE OF THE GUIDE WIRE WAS NOT RETRIEVED AND LEFT IN THE PATIENT'S CORONARY ARTERY. ANOTHER PCI IS PLANNED TO BE PERFORMED IN A MONTH TO STENT THE REMAINING PIECE OF THE GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572375 GLADIUS MONGO PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 230119A021 04547327123693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability