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

Model Number	25335
Medical Device Problem Codes	Contamination (1120); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sterility issue occurred.The target lesion was located in the superficial femoral artery.An encore 26 inflation device was selected for debulk procedure.Prior to the procedure, the packaging did not open properly, and the sterility of the device was compromised.The tear tab remained intact.No issues were noted with the packaging prior to opening, and no physical damage was observed.The device was not used during the procedure.The procedure was completed with an alternate device with no reported patient complications.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the encore device returned for analysis.A visual inspection revealed that a portion of the device's pouch had become stuck to the seal of the plastic tray.A review of the media shows pictures where portions of the inner pouch got stuck on the seal on the plastic tray where the encore device is packaged while it was being removed.The reported issues of packaging damaged/defective and device not sterile were confirmed.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a sterility issue occurred.The target lesion was located in the superficial femoral artery.An encore 26 inflation device was selected for debulk procedure.Prior to the procedure, the packaging did not open properly, and the sterility of the device was compromised.The tear tab remained intact.No issues were noted with the packaging prior to opening, and no physical damage was observed.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: 23415775
• Report Number: 2124215-2025-77757
• Device Sequence Number: 15724500
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: (01)08714729183624(17)270502(10)36426028
• 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
• Report Date (Section B): 12/23/2025

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: 0036426028
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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