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

Model Number	25-5211
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that while attempting to fix a right coronary artery (rca) and posterior left branch (plb) branch, the doctor placed three (3) stents and had two (2) wires in the vessel.After the deployment of the 3rd stent in the drca, the doctor went to pull the wire out and felt some resistance.After the wire was removed, he noticed that the tip of the wire had detached from the body of the wire.They had to snare out the wire tip and the patient was stable.The procedure performed was a percutaneous transluminal coronary angioplasty (ptca_ of the rca/plb.The estimated blood loss was less than 250cc's.The reported event did not result in patient injury and/or require medical or surgical intervention.

• 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: 19809048
• Report Number: 2243441-2024-00022
• Device Sequence Number: 12859399
• Product Code: DQX
• UDI-Device Identifier: 04987350734709
• UDI-Public: (01)04987350734709(17)260630(10)230731
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2024
• Report Date (Section F): 07/23/2024

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 Expiration Date: 06/30/2026
• Device Model Number: 25-5211
• Device Catalogue Number: TW*AS418XHW
• Device Lot Number: 230731
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2024
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• 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 Age: 79 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/23/2024