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

Model Number	25335
Medical Device Problem Codes	Contamination (1120); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sterility issue occurred.An encore 26 inflation device was selected for use during an endovascular procedure.Prior to procedure, it was noted that the protective paper covering the inner tray of the device is difficult to tear.There was no visible damaging to the packaging, however the sterility of the device was compromised.The device was not used during the procedure.The procedure was completed with an alternate device with no reported patient complications.
Additional Manufacturer Narrative
Manufacturer media review: the provided media shows that the pouch of the inner tray was difficult to remove confirming the reported event.
Event or Problem Description
It was reported that a sterility issue occurred.An encore 26 inflation device was selected for use during an endovascular procedure.Prior to procedure, it was noted that the protective paper covering the inner tray of the device is difficult to tear.There was no visible damaging to the packaging, however the sterility of the device was compromised.The device was not used during the procedure.The procedure was completed with an alternate device with no reported patient complications.
Additional Manufacturer Narrative
Correction: h6 component codes and evaluation result codes.Manufacturer media review: the provided media shows that the pouch of the inner tray was difficult to remove confirming the reported event.
Event or Problem Description
It was reported that a sterility issue occurred.An encore 26 inflation device was selected for use during an endovascular procedure.Prior to procedure, it was noted that the protective paper covering the inner tray of the device is difficult to tear.There was no visible damaging to the packaging, however the sterility of the device was compromised.The device was not used during the procedure.The procedure was completed with an alternate device with no reported 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23293600
• Report Number: 2124215-2025-72991
• Device Sequence Number: 11961499
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: (01)08714729183624(17)270410(10)36278820
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 01/26/2026

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: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0036278820
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 01/21/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025; 01/26/2026
• Date Device Manufactured: 04/10/2025
• 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