MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI GAIA PV18; PERIPHERAL GUIDE WIRE

Model Number	PHW18R302P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an endovascular treatment (evt) was performed for a heavily calcified and severely flexuous chronic total occlusion (cto) in the popliteal artery.An attempt was made with an asahi gaia pv guide wire retrogradely from the posterior tibial artery to the popliteal artery to approach the cto cap in the popliteal artery.The gaia pv guide wire wandered in between the cto and the subintimal space, and stopped torqueing due to the entrapment.The physician tried spinning the guide wire to advance through the lesion, but the guide wire would not move.When the physician removed the gaia pv guide wire, the wire began to unravel and got detached, leaving a wire fragment in the posterior tibial artery.It was informed that surgical treatment was performed to remove the fragment of the gaia pv guide wire, and the patient was doing fine afterwards.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.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 other similar product experience report was received from this lot.Based on the obtained information, lot history review, and referring to known similar events, it was presumed that torsional stress exceeding the product design limit might have been applied to the subject gaia pv guide wire as further torqueing manipulation was applied to the guide wire while it had been wander into the subintimal space and trapped there.Furthermore, tensional stress was applied to the guide wire during withdrawal attempts.Consequently, the distal segment of the guide wire was fractured and detached.Although it was concluded that the reported event was not attribute to the product quality, removal of the wire fragment by surgery was an additional treatment and therefore reportable.Capa: no capa will be taken.The instructions for use (ifu) states: [warnings] observe guide wire movement in the vessels.Before a guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque a 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 guide wire and its location in the vessel are visible during wire manipulations.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.[malfunctions and adverse events].Separation or breakage of the guide wire.

• Brand Name: ASAHI GAIA PV18
• Common Device Name: PERIPHERAL 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: yukimi nagumo ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 22033349
• Report Number: 3003775027-2025-00141
• Device Sequence Number: 18512410
• Product Code: DQX
• UDI-Device Identifier: 04547327106917
• UDI-Public: (01)04547327106917(17)271130(10)241129A251
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150445
• 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): 05/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PHW18R302P
• Device Lot Number: 241129A251
• 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: 04/28/2025
• Initial Report FDA Received Date: 05/16/2025
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown