MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	GM1831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the patient experienced hemoptysis during the cardiomems implant procedure.The hemoptysis occurred prior to cardiomems insertion, shortly after the physician obtained the patient's wedge pressure using a multipurpose catheter.The sensor was successfully deployed and calibrated.The patient was given supplemental oxygen and was admitted to the intensive care unit in stable condition.No further information could be obtained.The terumo wire was used for the procedure.

• Brand Name: RADIFOCUS GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 20356322
• Report Number: 2243441-2024-00026
• Device Sequence Number: 20832195
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: (01)04987350711908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/02/2024
• Report Date (Section F): 10/02/2024

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: GM1831
• Device Catalogue Number: RF*RA18303TA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/03/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2024
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/02/2024