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

Model Number	25335
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that packaging seal was compromised.An encore 26 peripheral intervention inflation device was selected for use.Prior procedure, it was noted that the protective paper tears easily due to the blister package of the boston scientific inflation pumps.There was no visible damage to the outer packaging, however, a potential risk of sterility being compromised due to the torn paper layer that may have come into contact with both the outer and inner surfaces of the packaging and the device itself.There were no patient complications.
Additional Manufacturer Narrative
A visual inspection of the device showed that the device's pouch was stuck on the seal of the plastic tray.In this case, the device returned for product analysis, but it was not possible to identify the most probable cause of the reported event.This investigation has been assigned the conclusion code cause not established.
Event or Problem Description
It was reported that packaging seal was compromised.An encore 26 peripheral intervention inflation device was selected for use.Prior procedure, it was noted that the protective paper tears easily due to the blister package of the boston scientific inflation pumps.There was no visible damage to the outer packaging, however, a potential risk of sterility being compromised due to the torn paper layer that may have come into contact with both the outer and inner surfaces of the packaging and the device itself.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 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: 23437178
• Report Number: 2124215-2025-78441
• Device Sequence Number: 12899572
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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