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

Model Number	GR3508
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical obtained an fda medwatch report # mw5157027.The event description states: that a tips procedure was carried out, during which a 180cm angled glidewire with a hydrophilic coating was utilized.During the process, part of the coating detached from the wire within the liver.The stripped coating is visible under fluoroscopy and, being irretrievable, remains in the liver.

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• MDR Report Key: 20158764
• Report Number: 2243441-2024-00025
• Device Sequence Number: 8369091
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: (01)04987350773197(17)250930(10)231017
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/06/2024
• Report Date (Section F): 06/28/2024

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: 09/30/2025
• Device Model Number: GR3508
• Device Catalogue Number: RF*GA35183A
• Device Lot Number: 231017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/07/2024
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 06/28/2024