MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Encore 26; syringe, balloon inflation

Model Number	M0067101131
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that encore was to be used in a procedure.During procedure, the pressure was not registered when the balloon was inflated.There were no patient complications reported.No further information was reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Approximated event date used was (b)(6) 2026.

• Brand Name: Encore 26
• Common Device Name: syringe, balloon inflation
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; business and technology park,; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50755254
• Report Number: 2124215-2026-48907
• Device Sequence Number: 9195288
• Product Code: MAV
• UDI-Device Identifier: 08714729761815
• UDI-Public: (01)08714729761815(17)290501(10)40465835
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: M0067101131
• Device Catalogue Number: 710-113
• Device Lot Number: 0040465835
• 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: 08/18/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 05/02/2026
• 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
• Patient Sex: Unknown