MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI GLADIUS MONGO14; PTCA GUIDE WIRE

Model Number	AP14R023S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).The reported gladius mongo 14 guide wire was returned for evaluation.The polymer jacket of the returned gladius mongo 14 guide wire was found torn off at approximately 84mm distal to the proximal solder (set at 85mm from the tip for the purpose of fixing the outer coil onto the core).The outer coil was found stretched and fractured for approximately 2mm from the torn end of the polymer jacket.The inner coil was found fractured at approximately 87mm distal to the proximal solder.The separated wire fragment was not returned.The polymer jacket was removed for observation purpose.The fracture end of the core was observed at approximately 75mm distal to the proximal solder.The inner coil was found slight loosened due to torsion, stretched and fractured at approximately 87mm distal to the proximal solder.Originating from approximately 75mm distal to the proximal solder, the outer coil was found stretched distally for approximately 45mm.Observation by scanning electron microscope (sem) found that the fracture end of the outer coil had a flat fracture surface, indicating that the fracture of the outer coil was attributed to torsion.The core fracture end was necked by tensile stress.Measurement of the returned guide wire suggested that the outer coil was fractured at approximately 6mm from the tip, the inner coil was fractured at the joint segment with the distal tip and the core was fractured at approximately 10mm from the tip.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 stress generated with torquing manipulation as well as pushing and pulling manipulation while the gladius mongo 14 guide wire was trapped by the stent strut might have been accumulated on the wire tip when the guide wire was advanced into the stent to treat the in-stent restenosis.Consequently, the guide wire was fractured.Although it was concluded that this event was not attributed to product quality, removal of the wire fragment by snaring was considered as an additional treatment.Therefore, it was concluded that this event was reportable.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.
Event or Problem Description
It was reported that a percutaneous coronary intervention (pci) was performed to treat a mildly tortuous, heavily calcified chronic total occlusion (cto) in the right coronary artery (rca).When attempts were made to cross the in-stent restenosis with an asahi gladius mongo 14 guide wire, the wire tip was fractured.The wire fragment was removed by snaring and the procedure was completed successfully.It was informed that the patient was fine after the procedure.

• Brand Name: ASAHI GLADIUS MONGO14
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 20922247
• Report Number: 3003775027-2024-00131
• Device Sequence Number: 12833483
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)270531(10)240531A421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP14R023S
• Device Lot Number: 240531A421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown