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

Model Number	72404133
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported issues with size incorrect for patient may have been due to a potential measurement error.The reported issues with malposition of device may have been due to a potential placement error.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.D4.Concomitant product udi for balloon is (b)(4) and for the pump is (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring urinary incontinence.The physician stated that the cuff did not achieve adequate urethral compression and noted that the balloon was positioned very deep within the retropubic space.As a result, the balloon was explanted and replaced with a higher-pressure balloon.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: 24442442
• Report Number: 2124215-2026-10360
• Device Sequence Number: 18735189
• Product Code: EZY
• UDI-Device Identifier: 00878953003115
• UDI-Public: (01)00878953003115(17)260307(10)1100465988
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/25/2026

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: 03/07/2026
• Device Model Number: 72404133
• Device Catalogue Number: 72404133
• Device Lot Number: 1100465988
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 03/07/2024
• 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: 1100713126; PUMP. UPN: 72404127 LOT: 1100621042
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male