MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 ARTIFICIAL URINARY SPHINCTER; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400161
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Decrease in Pressure (1490)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom is a known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100446018.Model/catalog description: balloon.Unique identifier (udi) # (b)(4).Model number/catalog number: 72400098.Serial number: n/a.Batch/lot number: 1100564838.Model/catalog description: pump.Unique identifier (udi) # (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring urinary incontinence.The device was not functioning properly, as the cuff did not achieve full coaptation and the balloon did not maintain appropriate system pressure.No visible kinks or disconnections were noted, though a slow leak could not be ruled out.As a result, the device was explanted and replaced.No further patient complications were reported.

• Brand Name: AMS 800 ARTIFICIAL URINARY SPHINCTER
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24742504
• Report Number: 2124215-2026-17526
• Device Sequence Number: 8759456
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)270726(10)1100164280
• Combination Product (Y/N): N
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 03/31/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 1100164280
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 07/27/2022
• 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