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

Model Number	72400161
Medical Device Problem Codes	Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
Date of Event	11/18/2025
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 symptoms are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) experienced recurrent urinary incontinence, requiring daily use of diapers.The physician indicated that this was likely due to a mechanical problem or urethral atrophy.A sizing issue with the cuff was also noted.A revision surgery has been scheduled.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) experienced recurrent urinary incontinence, requiring daily use of diapers.The physician indicated that this was likely due to a mechanical problem or urethral atrophy.A sizing issue with the cuff was also noted.A revision surgery has been scheduled.No additional patient complications were reported.
Additional Manufacturer Narrative
Correction to field h11: concomitant information.Model number/catalog number: 72400098.Serial number: n/a.Batch/lot number: 1100436055.Model/catalog description: control pump fgs.Unique identifier (udi) #: (b)(4) model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100455804.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4) the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device instructions for use (ifu) was reviewed.The reported patient symptom of urinary incontinence and atrophy were found to be listed in the ifu.A risk review was completed and confirmed that the event of urinary incontinence, atrophy, mechanical issue, and size incorrect for patient was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Therefore, a conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 23820994
• Report Number: 2124215-2025-91191
• Device Sequence Number: 10104764
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)280805(10)1100340619
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 07/09/2026

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: 1100340619
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 06/17/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/11/2026; 07/09/2026
• Date Device Manufactured: 08/07/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male