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

Model Number	72400164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).Concomitant product udi for pump is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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 this artificial urinary sphincter (aus) developed pain near the pump site, followed by edema and inflammation.The patient was started on antibiotic therapy, but the condition progressed to erosion and exteriorization of the pump through the right labia majora.Clinical evaluation confirmed a localized infection at the pump site.A surgical procedure was performed in which the device was removed as an emergency intervention.There were no further patient complications 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: 23577486
• Report Number: 2124215-2025-83534
• Device Sequence Number: 18447331
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: (01)00878953000756(17)260107(10)1000512043
• 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: 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
• Report Date (Section B): 11/17/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/07/2026
• Device Model Number: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 1000512043
• 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: 10/22/2025
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 01/08/2021
• 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: LOT:1100448269 UPN:72400098. PUMP.; LOT:1100571297 UPN:72400024. BALLOON.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown