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	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that packaging seal was compromised.The target lesion was located in the superficial femoral artery.An encore 26 peripheral intervention inflation device was selected for use.Prior procedure, it was noted that the protective paper tears easily and some pump was sticking to the plastic blister.There were 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.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Correction to lot/batch number.The returned device consisted of the encore device.A visual examination revealed that the pouch was stuck on the seal of the plastic tray, confirming the reported allegation.This investigation has been assigned the conclusion code cause not established following a review of the reported event details, available information, and product record review.In this case, the device returned for product analysis, but it was not possible to identify the most probable cause of the reported event.
Event or Problem Description
It was reported that packaging seal was compromised.The target lesion was located in the superficial femoral artery.An encore 26 peripheral intervention inflation device was selected for use.Prior procedure, it was noted that the protective paper tears easily and some pump was sticking to the plastic blister.There were 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.The procedure was completed with another of the same 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 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: 23379256
• Report Number: 2124215-2025-76444
• Device Sequence Number: 15753675
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: (01)08714729183624
• 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: 0036278820
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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