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

Model Number	72404127
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Difficult or Delayed Activation (2577); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720157-01.Serial number: n/a.Batch/lot number: 1100321438.Model/catalog description: cuff fgs 3.5 cm inhibizone.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100697088.Model/catalog description: balloon fgs 61-70 cm.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 is acknowledged within the instructions for use (ifu) and is not related to off-label use or failure to follow instructions.The reported patient symptoms of urinary incontinence is a known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that a patient implanted with an artificial urinary sphincter (aus) experienced recurrent incontinence and presented with a nonfunctioning device.During a revision surgery, the physician confirmed that the device did not coapt.It was reported that the pump remained locked and did not refill, with pump collapse dimpling observed, reportedly due to a fluid leak in the system.The device was explanted and replaced.There were no further patient complications.

• 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: 25256599
• Report Number: 2124215-2026-27689
• Device Sequence Number: 20207545
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: (01)00878953003078(17)270313(10)1100693041
• 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: 2025
• Device Explanted Year: 2026
• 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): 06/25/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1100693041
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 03/13/2025
• 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 Age: 51 YR
• Patient Sex: Male