MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER; BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRA

Model Number	M00543000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a spy discover balloon was used during a procedure performed in the common bile duct (cbd) on an unknown date.During the procedure, the physician used a discover balloon to access and visualize the cbd.The patient was found to have a stricture and subsequently required stent placement.The patient had to be transferred to another hospital for stent placement.It was reported that the patient had a stricture and required hospital admission beyond the standard of care but was subsequently discharged.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf patient code e2337 captures the reportable event of stenosis.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f08 captures the reportable event hospitalization or prolonged hospitalization.

• Brand Name: SPYGLASS DISCOVER
• Common Device Name: BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25319697
• Report Number: 3005099803-2026-02176
• Device Sequence Number: 21328500
• Product Code: GCA
• UDI-Device Identifier: 00191506013516
• UDI-Public: (01)00191506013516
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K212582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2026

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: M00543000
• Device Catalogue Number: M00543000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown