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

Model Number	GM1831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemoptysis (1887)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample was not available; therefore, investigation of it could not be performed.History investigation of the involved product code and lot number: - since the involved lot number was unknown, history investigation could not be performed.- no incidents due to manufacturing defects have been reported for the products with the involved product code within the past two years.Udi number is not listed since the involved lot number is unknown.Di no.: (b)(4).(cause of occurrence): since the lot number was unknown, the manufacturing record and the shipping inspection record could not be investigated.In addition, since the actual sample was not returned and the analysis of it could not be performed, it was not possible to clarify the cause of occurrence.Instructions for use (ifu) of this product includes the following warning: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel." please see mdr 2243441-2024-00026 for the importer report.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to section b5, e4, g2, and h6: health effect - impact code.
Event or Problem Description
On 11 oct 2024 terumo medical received fda medwatch report # mw5159484: it was 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 (b)(6) wire was used for the procedure.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RADIFOCUS GUIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 265 davidson ave; suite 320; somerset 08873 ; 9499890491
• MDR Report Key: 20356325
• Report Number: 9681834-2024-00168
• Device Sequence Number: 8086300
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: (01)04987350711908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown