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

Model Number	72400161
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Codes	Fluid Discharge (2686); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) presented with fluid discharge, and the device was not working as expected.A replacement surgery has been requested.No additional information was provided.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Correction to field b2: outcomes attrib to adv event.Correction to field h1: type of reportable event.Correction to field h6: patient codes.Correction to field h6: device codes.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 analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.With all the information available, boston scientific concludes that the reported allegation of fluid loss, is unlikely to cause or contribute to a death or serious injury if the event were to occur.Therefore, the event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not working as expected as it exhibited with fluid loss.A replacement surgery has been requested.No additional information was provided.

• 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: 23344064
• Report Number: 2124215-2025-74893
• Device Sequence Number: 9461527
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)290724(10)1100556584
• 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: 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): 12/02/2025

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: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 1100556584
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 07/25/2024
• 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: BALLOON: UPN: 72400024 / LOT: 1100609763; BALLOON: UPN: 72400024 / LOT: 1100609763; PUMP: UPN: 72404127 / LOT: 1100693751; PUMP: UPN: 72404127 / LOT: 1100693751
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male