MAUDE Adverse Event Report: Atrion Medical Products, Inc. Boston Scientific Encore 40 Inflation Device

Model Number	M001394472540
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Malfunction

• Brand Name: Boston Scientific Encore 40 Inflation Device
• Common Device Name: Inflation Device
• Manufacturer (Section D): Atrion Medical Products, Inc.; 1426 curt francis road; arab AL 35016
• Manufacturer (Section G): ATRION MEDICAL PRODUCTS INCORPORATE; po box 934372; atlanta GA 31193 -437
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 50058413
• Report Number: 2124215-2026-40357
• Device Sequence Number: 10731064
• Product Code: MAV
• UDI-Device Identifier: 00856877002445
• UDI-Public: (01)00856877002445(17)290228(10)96505041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: M001394472540
• Device Catalogue Number: M001394472540
• Device Lot Number: 0096505041
• 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: 07/03/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 02/28/2026
• 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
• Patient Sex: Male