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

Model Number	72400023
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent incontinence.A cystoscopy was performed and revealed that although the cuff was closed, the urethra remained open.It was considered that the cuff size might no longer be appropriate.During surgery, it was confirmed that the pressure-regulating balloon was leaking saline solution.The device components were removed and replaced.There were no further patient complications reported.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The balloon was visually and microscopically examined, leak and functionally tested.The balloon passed the leakage test; therefore, the reported balloon fluid loss was not confirmed.However, the balloon did not pass the functional test due to pressure reading above specification.In addition, microscope examination revealed that the tubing had worn to the filament and the balloon was identified to have folds.The cuff was visually examined, and leak tested.The cuff had a hole and subsequent fluid leakage from wear and fatigue.The cuff did not pass the visual and leakage tests.The pump was visually examined, leak and functionally tested.No anomalies were found with the pump.Based on analysis results, the identified fluid leak in the cuff could have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent incontinence.A cystoscopy was performed and revealed that although the cuff was closed, the urethra remained open.It was considered that the cuff size might no longer be appropriate.During surgery, it was confirmed that the pressure-regulating balloon was leaking saline solution.The device components were removed and replaced.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: 22375169
• Report Number: 2124215-2025-43147
• Device Sequence Number: 19930674
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: (01)00878953000619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 08/08/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72400023
• Device Catalogue Number: 72400023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown