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

Model Number	72400161
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
C2/d10 concomitant product information: udi for balloon (b)(4), udi for pump (b)(4).The device was not available for analysis; therefore, no physical evaluation could be performed and the reported device performance allegation could not be confirmed.Urinary incontinence is acknowledged within the dfu and is not associated with off label use or failure to follow instructions.Based on the device history record (dhr), the device met specifications prior to shipment, indicating that manufacturing was not related to the reported event.Without a returned device and based on the information available, a clear probable cause for the event could not be established; therefore, the conclusion code unable to exclude device problem has been selected.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent incontinence with a nonfunctioning device, particularly when changing position or when sitting on a chair that was too low.A fibroscopy revealed an overly wide cuff imprint; therefore, a revision surgery was performed.Examination of the ex vivo components showed no evidence of leakage from the cuff, balloon, or tubing.Physician suspected from a valve or pressure issue.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: 24274741
• Report Number: 2124215-2026-06780
• Device Sequence Number: 10725910
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)250804(10)1000442246
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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 Expiration Date: 08/04/2025
• Device Model Number: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 1000442246
• 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: 01/09/2026
• Initial Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 08/05/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON LOT 1100168197, UPN 72400024; PUMP LOT 1100188216, UPN 72400098
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male