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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the wire tip broke off during the case.It is possible that the tip of the wire was caught on a stent strut or was behind the stent when the wire was removed.The wire tip was left in the patient.The type of procedure performed was a percutaneous coronary intervention (pci) via right radial access.Additional information was received on 16apr2024: the wire was not retrieved as it was deemed too risky.Additional information was received on 24apr2024: there are no plans on collecting the broken piece from the patient.Patient was stable.Terumo medical received a user facility medwatch report # (b)(4) on 03may2024.The event description states: "middle-aged male with recent history of chest pain.Procedure: cardiac catheterization with stent.During the procedure, the terumo runthrough wire tip broke in the vessel.The tip is retained in the native lad (left anterior descending artery).The tip was left in by decision.No known harm to patient at this time.Patient discharged the next day.".

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 19309951
• Report Number: 2243441-2024-00013
• Device Sequence Number: 15189142
• Product Code: DQX
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2024
• Report Date (Section F): 05/14/2024

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: N/A
• Device Catalogue Number: 25-1011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/15/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• 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: Male
• Date Report Sent to FDA: 05/14/2024