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

Model Number	25-1011
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Perforation (2001); Foreign Body In Patient (2687)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a high-risk percutaneous coronary intervention (pci) in a very tortuous om branch of the circumflex artery.There was no trouble getting the run-through wire down past the area of interest with a "safety loop" although it did straighten out a very significant loop in the artery.When the physician tried to pull the run-through wire back, he stated that the wire "was stuck".He did not pull hard; however, did some gentle tugging on the wire a couple times and the wire ended up breaking off inside the coronary artery.We were unable to retrieve the distal end of the wire, and the patient was not a surgical candidate.Therefore, the physician decided to pin the wire by placing three (3) stents to cover the wire from the distal part of the artery all the way to the ostium.This was an outpatient planned pci.The patient went to the lab stable, and all vitals were within normal limits.The blood loss was less than 250 cc.The remaining wire was wiped clean, then placed in a biohazard bag post procedure.Additional information was received on 15aug2025: the images were reviewed, which did demonstrate a highly tortuous om artery.The vessel was perforated; however, it was reported that the broken segment of the wire did not cause the perforation.A balloon (sapphire) was used with the wire.The patient was stable.

• 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: 22939580
• Report Number: 2243441-2025-00047
• Device Sequence Number: 13227899
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)280229(10)250307
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/02/2025
• Report Date (Section F): 09/02/2025

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: 250307Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/08/2025
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON (SAPPHIRE)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 09/02/2025