MAUDE Adverse Event Report: Boston Scientific Corporation EluPro Antibiotic-Eluting BioEnvelope

Model Number	BE03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this bioenvelope pocket revision procedure was performed due to a hematoma.The patient was reported to be stable following the intervention.The explanted device was not returned for analysis because it was heavily contaminated with blood and was discarded.No additional adverse patient effects were reported.This product is not expected to return.

• Brand Name: EluPro Antibiotic-Eluting BioEnvelope
• Common Device Name: Bioenvelope
• Manufacturer (Section D): Boston Scientific Corporation; 1100 old ellis rd; suite 1200; roswell GA 30076
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION BOSTO; 110 old ellis rd suite 1200; roswell GA 30076
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50178278
• Report Number: 2124215-2026-42481
• Device Sequence Number: 9880790
• Product Code: FTM
• UDI-Device Identifier: 00802526630019
• UDI-Public: (01)00802526630019
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: D583161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BE03
• Device Catalogue Number: BE03
• Device Lot Number: M26E1172
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 03/24/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown