MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH; WIRE, GUIDE, CATHETER

Model Number	25-1011
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that they had performed a percutaneous coronary intervention (pci) with pre-dilatation ballooning and stenting of both an om2 and mid-circumflex.It went successfully and they re-positioned the runthough wire into other vessels left anterior descending artery (lad) and diag and performed ballooning and stenting to the other vessels, also successfully and uneventfully.They then saw a flow defect in the ostial/prox om2 stented area.They turned their attention back to the om2 and re-wired the circ and om2 which was the stented portion.They passed a 2.5 x 6 balloon in an attempt to balloon the defect however, the balloon would not advance to the lesion.At that time the wire could not be removed.During the attempt to remove the wire the distal tip of the runthough wire broke off.It did not seem to migrate, and the flow did not seem disrupted.An attempt was made to pass a stent down to trap the wire in place however, that was unsuccessful.They ended the procedure at that time.The patient was in good condition.There was no blood loss.Additional information was received on 16jul2025: no other terumo products were used in combination with the wire.The fragment of the wire was left inside the patient and it has not been removed.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 22709219
• Report Number: 2243441-2025-00042
• Device Sequence Number: 9357873
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)280131(10)250204
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2025
• Report Date (Section F): 08/04/2025

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: 25-1011
• Device Catalogue Number: TW*AS418XA
• Device Lot Number: 250204Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2025
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/04/2025