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

Model Number	M00566670
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an encore 26 inflation device was being prepared to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During preparation, the gauge barometer failed.The procedure was completed with another encore 26 inflation device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0902 captures the reportable event of inflation device gauge inaccurate reading.Block h11: investigation results the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.With all available information, boston scientific concludes the reported event of inflation device gauge inaccurate reading could not be confirmed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A similar complaint review was completed.There were no emerging trends identified that warrant further action.

• 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 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 ; +1(914)571-6918
• MDR Report Key: 50748342
• Report Number: 3005099803-2026-03741
• Device Sequence Number: 8542637
• Product Code: PTM
• UDI-Device Identifier: 08714729755241
• UDI-Public: (01)08714729755241(17)290326(10)38944338
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: M00566670
• Device Catalogue Number: M00566670
• Device Lot Number: 0038944338
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 03/27/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male