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

Model Number	72400164
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.D4.Concomitant product udi for pump is (b)(4) and for balloon is for (b)(4).
Event or Problem Description
It was reported that since device activation, the patient with an artificial urinary sphincter (aus) experienced recurring urinary incontinence.The issue may be related to a loose cuff, balloon not functioning properly, and improper pump inflation.Troubleshooting attempts were unsuccessful.The device remains implanted, and surgery is planned.No further patient complications have been reported.
Event or Problem Description
It was reported that since device activation, the patient with an artificial urinary sphincter (aus) experienced recurring urinary incontinence.The issue may be related to a loose cuff, balloon not functioning properly, and improper pump inflation.Troubleshooting attempts were unsuccessful.The device remains implanted, and surgery is planned.No further patient complications have been reported.
Additional Manufacturer Narrative
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.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.D4.Concomitant product udi for pump is (b)(4) and for balloon is for (b)(4).
Additional Manufacturer Narrative
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.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of urinary incontinence and mechanical issue was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.Based on the information available, the conclusion codes of unable to exclude device problem and known inherent risk of device were assigned to this investigation.Model number/catalog number: 72400098 serial number: n/a batch/lot number: 1100547434 model/catalog description: pump unique identifier (udi) # (b)(4).Model number/catalog number: 72400024 serial number: n/a batch/lot number: 1100450179 model/catalog description: balloon unique identifier (udi) # (b)(4).
Event or Problem Description
It was reported that since device activation, the patient with an artificial urinary sphincter (aus) experienced recurring urinary incontinence.The issue may be related to a loose cuff, balloon not functioning properly, and improper pump inflation.Troubleshooting attempts were unsuccessful.The device remains implanted, and surgery is planned.No further patient complications have been 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: 23862797
• Report Number: 2124215-2025-92235
• Device Sequence Number: 21184477
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: (01)00878953000756(17)250809(10)1000443344
• 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: 2024
• 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,Followup
• Report Date (Section B): 03/26/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/09/2025
• Device Model Number: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 1000443344
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/03/2026; 02/27/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/27/2026; 03/26/2026
• Date Device Manufactured: 08/10/2020
• 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 1100450179; BALLOON: UPN 72400024 LOT 1100450179; PUMP: UPN 72400098 LOT 1100547434; PUMP: UPN 72400098 LOT 1100547434
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male