MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device incontinence mechanical/hydraulic

Model Number	720133-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced recurring incontinence.The device exhibited fluid loss due to a hole in the cuff.As a result, the aus was removed and replaced.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72400098.Serial number: n/a batch/lot number: 749963002.Model/catalog description: control pump fgs.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 595132004.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.Recurrent incontinence, fluid leak and hole/perforated are acknowledged within the directions for use (dfu) and are not related to off-label use or failure to follow instructions.A risk review was completed; altered therapeutic response, and fluid leak are defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The reported patient symptom of urinary incontinence is a known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 25368126
• Report Number: 2124215-2026-29523
• Device Sequence Number: 9966716
• Product Code: EZY
• UDI-Device Identifier: 00878953005461
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 08/06/2013
• Device Model Number: 720133-01
• Device Catalogue Number: 720133-01
• Device Lot Number: 725179012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 08/12/2011
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown