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	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1-initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device contamination occurred.An encore inflation device was selected for use.Packaging was damaged during transport.The inner pouch was also damaged and the sterility of the device was compromised.There was no patient involved.
Additional Manufacturer Narrative
Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Media review: the media attached to the parent record shows the device packaging box crush and damaged but does not show any evidence of the damage reported in the inner pouch of the encore device.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the device confirmed that the event of packaging seal compromised, packaging damaged/defective is a known event defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the device is acceptable.Investigation conclusion: this investigation has been assigned an investigation conclusion code of cause traced to transport/storage, following a review of the reported event details, available information, and product record review.It is likely that the issues could occurred during transportation or storage of the device.Furthermore, batch record review concluded that no manufacturing deviations were identified during the manufacturing process.Therefore, cause traced to transport/storage is selected as the cause code for the reported issues.E1-initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device contamination occurred.An encore inflation device was selected for use.Packaging was damaged during transport.The inner pouch was also damaged, and the sterility of the device was compromised.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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24743766
• Report Number: 2124215-2026-17553
• Device Sequence Number: 9422400
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: (01)08714729183624(17)271201(10)38082373
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/20/2026

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: 0038082373
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/07/2026; 06/30/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/29/2026; 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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