MAUDE Adverse Event Report: TERUMO CORPORATION SINGLE USE GUIDEWIRE

Model Number	G-260-2545A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Peritonitis (2252); Perforation of Esophagus (2399); Bowel Perforation (2668); Pancreatitis (4481)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "efficacy of single-operator cholangioscopy-guided lithotripsy compared with large balloon sphincteroplasty in management of difficult bile duct stones in a randomized trial." background and aims: although single-operator cholangioscopy (soc)-guided lithotripsy and large balloon sphincteroplasty (lbs)-based techniques are effective rescue measures, the ideal approach to management of difficult bile duct stones is unclear.We conducted a randomized trial to compare the effectiveness of soc-guided lithotripsy and lbs-based approaches for endoscopic management of difficult bile duct stones.Methods: patients with difficult bile duct stones who failed retrieval using balloon or basket were randomly assigned to groups that received soc-guided laser lithotripsy (soc-ll, n [33) or lbs (n [ 33), from june 2016 through august 2018.When assigned treatment was unsuccessful, patients underwent mechanical lithotripsy before crossing over to the other group.The main outcome was treatment success, defined as ability to clear the duct in 1 session.Secondary outcomes were adverse events and treatment costs.Results: a higher proportion of patients in the soc-ll group had treatment success (93.9%) than in the lbs group (72.7%; p [.021).On multiple logistic regression analysis, treatment success was significantly associated with use of soc-ll (odds ratio [or], 8.7; 95% ci, 1.3¿59.3; p [.026), stone to extrahepatic bile duct ratio of 1 or less (or, 28.8; 95% ci, 1.2¿687.6; p [.038), and lack of a tapered bile duct (or, 26.9; 95% ci, 1.3¿558.2; p [.034).There was no significant difference between groups in adverse events (9.1% in the soc-ll group vs 3.0% in the lbs group, p [.61) or overall treatment cost ($16,684 in the soc-ll group vs $10,626 in the lbs group; p [.097).Type of adverse events/number of patients cricopharyngeal perforation (1 patient) bile peritonitis caused by perforation in the distal bile duct after laser lithotripsy (1 patient) mild post-ercp pancreatitis (1 patient) moderate severity post-ercp pancreatitis (1 patient) conclusion: in a randomized trial of patients with difficult bile stones that cannot be cleared by standard maneuvers, soc-guided lithotripsy leads to duct clearance in a significantly higher proportion of patients than lbs-particularly when stone size exceeds the diameter of the extrahepatic bile duct.Adjunct lithotripsy might be required in patients with tapered distal bile duct, because lbs alone is less likely to be successful.

• Brand Name: SINGLE USE GUIDEWIRE
• Common Device Name: SINGLE USE GUIDEWIRE
• Manufacturer (Section D): TERUMO CORPORATION; 44-1, 2-chome, hatagaya; shibuya-ku; tokyo 151-0 072; JA 151-0072
• MDR Report Key: 22929113
• Report Number: 2429304-2025-00237
• Device Sequence Number: 21388097
• Product Code: OCY
• UDI-Device Identifier: 04953170358241
• UDI-Public: 04953170358241
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial
• Report Date (Section B): 08/29/2025
• Report Date (Section F): 08/29/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: G-260-2545A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/04/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: B-V232P-A; FG-V422PR; KD-V411M-0725; TJF-Q180V
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/29/2025