MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device incontinence mechanical/hydraulic

Model Number	72404134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Urinary Incontinence (4572)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent incontinence and an inability to adequately coapt the urethra.During a revision surgery, the physician confirmed that the patient experienced incontinence due to atrophy.The cuff was explanted and replaced with a smaller cuff, and the remaining system components were retained.Additional information received stated that the cuff was appropriately sized and placed during the initial implant procedure.There were no further patient complications.
Additional Manufacturer Narrative
Model number/catalog number: 72404127 serial number: n/a batch/lot number: 1100794166 model/catalog description: control pump unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024 serial number: n/a batch/lot number: 1100604724 model/catalog description: pressure regulating balloon unique identifier (udi) #: (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.Recurrent incontinence and urethral atrophy are acknowledged within the instructions for use (ifu) and are not related to off-label use or failure to follow instructions.The reported patient symptoms of urinary incontinence and atrophy are known risk associated with this device type and indicated as such in the instructions for use.

• 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: 50857950
• Report Number: 2124215-2026-50490
• Device Sequence Number: 21316314
• Product Code: EZY
• UDI-Device Identifier: 00878953003122
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 09/11/2026
• Device Model Number: 72404134
• Device Catalogue Number: 72404134
• Device Lot Number: 1100587291
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 09/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male