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

Model Number	AP14R324S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 at the user facility and not returned.Lot history review revealed no anomaly relating to the reported event.No similar product experience was received for the subject lot other than a case (mfr report #: 3003775027-2026-00143, patient identifier: (b)(6), in which the polymer jacket of the guide wire was peeled due to tensile stress applied when the guide wire was trapped due to anatomical and lesion conditions.The event was not associated with product quality.Based on the obtained information, results of lot history review, and referring to known similar events, it was presumed thattensile stress or friction might have been locally applied on the distal segment of the gladius mongo 14 es guide wire during wire removal while the distal segment of the guide wire had been caught by the heavily calcified lesion.Consequently, the polymer jacket was peeled.It was concluded that this event was not attributed to product quality.As the affected device was not returned, it was unable to completely rule out that any polymer fragment was left in the patient anatomy.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] abrasion of the guide wire coating.
Event or Problem Description
It was reported that a percutaneous peripheral intervention (ppi) was performed for a heavily calcified lesion at the origin of the peroneal artery.The lesion was crossed with an asahi gladius mongo 14 es guide wire.After the gladius mongo 14 es guide wire was removed for wire exchange, peeling of the polymer jacket was observed, and the new guide wire could not be advanced.The device system was then removed and the procedure was restarted.It was informed that there were no adverse patient effects associated with this event and the patient was stable after the procedure.

• Brand Name: ASAHI GLADIUS MONGO14 ES
• Common Device Name: PERIPHERAL VASCULAR 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: 25851291
• Report Number: 3003775027-2026-00144
• Device Sequence Number: 5266553
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)281231(10)260108A161
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/17/2026

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: AP14R324S
• Device Lot Number: 260108A161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown