MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Encore 26 Advantage Kit; Syringe, Balloon Inflation

Model Number	2760
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material was present in the device.An encore 26 advantage kit was selected for use.During unpacking, a strand of hair was found inside the packaging.There were no patient complications.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to 09/01/2026 as no event date was reported.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.

• Brand Name: Encore 26 Advantage Kit
• Common Device Name: Syringe, Balloon Inflation
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Limited; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50893282
• Report Number: 2124215-2026-51102
• Device Sequence Number: 10684581
• Product Code: MAV
• UDI-Device Identifier: 08714729180005
• UDI-Public: (01)08714729180005
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K140745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 2760
• Device Catalogue Number: 2760
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown