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

Model Number	3040
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign matter was present in the device.An encore 26 single 0452601 was selected for use.During the procedure, it was noted that the manifold syringe used had a lot of plastic pieces that came out from inside the encore packaging.There was no damage noticed with the device, and the pieces did not appear to come from the device.There were no patient complications.
Additional Manufacturer Narrative
The device was returned in a plastic bag.A visual inspection of the device did not identify any failures or damages.There were black particles inside the barrel.Analysis of the device concluded that black particulates were inside the syringe of the encore device likely originated from flaking on the inner surface of the bourdon tube within the gauge.Based on the information provided and analysis performed, the issue may be attributable to the manufacturing process.This investigation has been assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that a foreign matter was present in the device.An encore 26 single 0452601 was selected for use.During the procedure, it was noted that the manifold syringe used had a lot of plastic pieces that came out from inside the encore packaging.There was no damage noticed with the device, and the pieces did not appear to come from the device.There were no patient complications.

• 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 LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24191030
• Report Number: 2124215-2026-04713
• Device Sequence Number: 9649591
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: (01)08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 3040
• Device Catalogue Number: 3040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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