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

Model Number	GR3508
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of guidewire fractured and broke off during the procedure.Tip migrated, unable to retrieve.

• Brand Name: TERUMO GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION
• MDR Report Key: 17949573
• Report Number: MW5147009
• Device Sequence Number: 6715658
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: (01)04987350773197
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: GR3508
• Device Catalogue Number: RF*GA35183A
• Device Lot Number: 221026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2023
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White