MAUDE Adverse Event Report: TERUMO CORPORATION VISIGLIDE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G-240-3545S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Preloaded double-sided wire used for procedure noted at end of procedure that opposite side of wire was inserted into bile duct during procedure.

• Brand Name: VISIGLIDE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 24578768
• Report Number: 24578768
• Device Sequence Number: 9233190
• Product Code: OCY
• UDI-Device Identifier: 04953170465123
• UDI-Public: (01)04953170465123
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/09/2026
• Report Date (Section F): 03/09/2026

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
• Device Model Number: G-240-3545S
• Device Catalogue Number: N3622731
• Device Lot Number: 56K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Date Report Sent to FDA: 03/09/2026