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

Model Number	72404142
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date is unknown, so estimated date was entered.C2/d10: concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Recurrent incontinence is acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 800 implantation and to prevent altered therapeutic response.Urethral atrophy is acknowledged within the dfu and is not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 800 implantation and to prevent atrophy.The reported patient symptom(s) 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) implant device experienced recurrent incontinence attributed to tissue atrophy.The aus device had no malfunction or issues.A surgical procedure was performed during which the physician explanted the cuff and replaced it with a downsized cuff.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 ; 5086521217
• MDR Report Key: 24274945
• Report Number: 2124215-2026-06784
• Device Sequence Number: 10621612
• Product Code: EZY
• UDI-Device Identifier: 00878953003184
• UDI-Public: (01)00878953003184(17)260829(10)1100580810
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/29/2026
• Device Model Number: 72404142
• Device Catalogue Number: 72404142
• Device Lot Number: 1100580810
• 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: 08/29/2024
• 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: 72400025 BALLOON FGS 71-80 CMH2O LOT: 1100513674.; 72404127 CONTROL PUMP FGS IZ LOT: 1100634354.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male