MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE¿ 26; SYRINGE, BALLOON INFLATION

Model Number	M001151050
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Fluid noted in tubing.

• Brand Name: ENCORE¿ 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 23061916
• Report Number: 23061916
• Device Sequence Number: 15868815
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: (01)08714729183624(17)270221(10)35909745
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2025
• Report Date (Section F): 09/08/2025

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: M001151050
• Device Lot Number: 35909745
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/08/2025