MAUDE Adverse Event Report: Asahi Intecc Co., Ltd. Astato XS 20; Peripheral Guide Wire

Model Number	PAGH143392
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percutaneous transluminal angioplasty (pta) was performed for a chronic total occlusion (cto) with moderately calcified fibrous cap of approximately 2cm in length in the mid anterior tibial artery (mid at).An asahi astato xs 20 guide wire was advanced to the fibrous cap and torqued to penetrate the cto, when the guide wire lodged in the cap.When the astato xs 20 guide wire was removed, the wire tip was found left in the cto.Additional attempts were made to cross the cto with other guide wires but failed.The procedure was aborted at that point.It was informed that there was blood flow to the foot through the posterior tibial artery, while the at remained occluded.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).Device investigation: device evaluation could not be performed because the affected device was not returned.Lot history records review: lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Conclusion: the cause of the reported event could not be identified as the subject device had not been yet returned to the manufacturer.Based on the obtained information, results of lot history records review, and referring to known similar events, it was presumed that tensional stress generated with withdrawal attempts might have been locally applied to the subject astato xs 20 guide wire while its distal segment had been lodged in the calcified cto cap after crossing attempts.Consequently, the guide wire got fractured.It was concluded that the reported event was not attributed to product quality.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."[malfunction and adverse effects]" separation of the guide wire.

• Brand Name: Astato XS 20
• 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: 50003511
• Report Number: 3003775027-2026-00147
• Device Sequence Number: 10659690
• Product Code: DQX
• UDI-Device Identifier: 04547327088305
• UDI-Public: (01)04547327088305(17)280430(10)250507A221
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103057
• 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,Followup
• Report Date (Section B): 07/30/2026

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: PAGH143392
• Device Lot Number: 250507A221
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/30/2026
• 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: Disability
• Patient Age: 86 YR
• Patient Sex: Female