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	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a cardiac catheterization interventional cardiology procedure, the tip of the involved runthrough ns broke off and was left behind in the patient's coronary artery.No further intervention was performed, and the patient was stable.No blood loss was reported.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 29 feb 2024: other devices used included three (3) different pca balloons (2.0x15, 1.0x10, 2.0x8nc) tig catheter, ebu catheter, wire extension, turnpike catheter, and 2.25x18 drug eluding stent.

• 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: 18923783
• Report Number: 2243441-2024-00005
• Device Sequence Number: 20753743
• Product Code: DQX
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/18/2024
• Report Date (Section F): 03/18/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2024
• 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: 2.25X18 DRUG ELUDING STENT; EBU CATHETER; PCA BALLOONS (2.0X15, 1.0X10, 2.0X8NC); TIG CATHETER; TURNPIKE CATHETER; WIRE EXTENSION
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/18/2024