MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE ADVANTAGE; 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	03/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a cerebral angiogram the tip of the guidewire advantage broke off and was inside the catheter.Then, was flushed out into the vessel.The wire was still in the vessel.There was no blood loss.The event occurred intra-operative.Additional information was received on 20 mar 2024: there was difficulty pushing the wire inside of the catheter, to the point of it not easily advancing, then the wire was pulled out and placed on the back scrub table.It was measured that 4mm of the nitinol tip was broken off.There was no interventional plan to go and remove the tip off the wire.The patient was as stable for their status as a post ruptured aneurysm.The patient has a history of meth usage, patient experienced a ruptured aneurysm and had a craniotomy.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 19042449
• Report Number: 2243441-2024-00007
• Device Sequence Number: 8565263
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024
• Report Date (Section F): 04/04/2024

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: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: GA3502
• Device Lot Number: 230623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/11/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• 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: GLIDEWIRE ADVANTAGE 035 260CM; SIMMONS CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 04/04/2024