BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIUS

    MDR report key: 17741911 · Received September 13, 2023

    Report

    Report Number
    3003775027-2023-00088
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    0454732710635
    PMA / PMN Number
    K150445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. THE SEPARATED FRAGMENT OF THE REPORTED GLADIUS WAS RETURNED FOR EVALUATION. THE RETURNED WIRE FRAGMENT WAS FOUND CURVED, DEFORMED IN A LOOP-LIKE SHAPE, OR BENT THROUGHOUT ITS LENGTH. THE BALL TIP WAS FOUND ATTACHED ON THE VERY DISTAL END OF THE WIRE FRAGMENT; THE FRAGMENT WAS THE DISTAL SEGMENT OF THE GLADIUS FOR APPROXIMATELY 165MM FROM THE TIP. THE POLYMER JACKED DISTAL TO THE FRACTURE END WAS FOUND DELAMINATED AND GATHERED PROXIMALLY, EXPOSING THE UNDERLYING SHAFT CORE. AT THE FRACTURE END, THE POLYMER JACKET WAS STRETCHED AND TORN. THE FRACTURED PROXIMAL END OF THE UNDERLYING SHAFT CORE WAS COMING OUT AT APPROXIMATELY 5MM DISTAL TO THE PROXIMAL TORN END OF THE POLYMER JACKET. THE POLYMER JACKET WAS THEN REMOVED FOR OBSERVATION. THE CORE FRACTURE END WAS FOUND TWISTED AND HAD A FLAT FRACTURE SURFACE. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND A CONCENTRIC-CIRCLE PATTERN OF DIMPLES ON THE RELATIVELY FLAT FRACTURE SURFACE OF THE CORE SHAFT. THESE FINDINGS INDICATED THAT ACCUMULATED TORSION HAD CONTRIBUTED TO THE OBSERVED FRACTURE OF THE SHAFT CORE. THE PROXIMAL SEGMENT OF THE GLADIUS WAS NOT 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 TO RETRIEVE THE GLADIUS WAS LOCALLY ACCUMULATED ON THE GUIDE WIRE WHILE THE MOVEMENT OF THE WIRE TIP WAS RESTRICTED BY THE ANATOMY, FRACTURING THE SHAFT CORE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. BECAUSE THE PROXIMAL SEGMENT OF THE GLADIUS GUIDE WIRE WAS NOT RETURNED, IT WAS UNABLE TO COMPLETELY RULE OUT THE POTENTIALITY THAT SOME WIRE FRAGMENTS MIGHT BE LEFT IN THE PATIENT. 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 LESION IN THE POPLITEAL ARTERY. AFTER AN ASAHI GLADIUS GUIDE WIRE WAS DELIVERED, THE PHYSICIAN TRIED TO PERFORM ABLATION WITH A NON-ASAHI SHOCKWAVE CATHETER AND THE CATHETER GOT STUCK WITH THE GLADIUS. WHEN THE PHYSICIAN TRIED TO REMOVE THE GLADIUS, THE TWISTED WIRE TIP WAS FRACTURED AND REMAINED IN THE PATIENT. AN INCISION WAS MADE TO REMOVE THE WIRE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357047 GLADIUS PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 221006A241 0454732710635

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R