MAUDE Adverse Event Report: ATRION MEDICAL PRODUCTS, INC. BOSTON SCIENTIFIC ENCORE 40 INFLATION DEVICE

Model Number	M001394472540
Medical Device Problem Code	Failure to Zero (1683)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): koe.
Event or Problem Description
It was reported that the gauge failed to zero.An encore 40 inflation device was selected for shunt percutaneous transluminal angioplasty.During the procedure, the pressure was lowered, but the gauge did not drop to zero.The indeflator was replaced, and the balloon was successfully removed.The procedure was completed with another of the same device.There was no patient injury and the patient was stable after the procedure.

• 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, INC.; po box 934372; atlanta GA 31193 4372
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22901432
• Report Number: 2124215-2025-57355
• Device Sequence Number: 8851266
• Product Code: MAV
• UDI-Device Identifier: 00856877002445
• UDI-Public: (01)00856877002445(17)280229(10)96505029
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: M001394472540
• Device Catalogue Number: M001394472540
• Device Lot Number: 0096505029
• 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: 08/01/2025
• Initial Report FDA Received Date: 08/27/2025
• Date Device Manufactured: 02/28/2025
• 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