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

Model Number	720157-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Air/Gas in Device (4062)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring urinary incontinence.Upon inspection, air bubbles were identified within the cuff and pump, along with associated fluid loss.In addition, the cuff was noted to be not inflating.As a result, the device was explanted and replaced.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this aus underwent a thorough analysis.The cuff was visually inspected and folds were observed.A leakage test was subsequently performed, and the cuff successfully passed with no abnormalities detected.The kink-resistant tubing (krt) was also subjected to both a visual inspection and a leakage test.Both evaluations were completed successfully, with no abnormalities observed.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 air in system, mechanical issue, fluid leak and urinary incontinence were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, the reported clinical observation of air in system/component, mechanical issue and fluid leak could not be confirmed.Model number/catalog number: 72404127 serial number: n/a batch/lot number: 1100935147 model/catalog description: control pump fgs iz unique identifier (udi) #:(b)(4).Model number/catalog number: 72400024 serial number: n/a batch/lot number: 1100916766 model/catalog description: balloon fgs 61-70 cm unique identifier (udi) #: (b)(4).

• 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: 50167826
• Report Number: 2124215-2026-42306
• Device Sequence Number: 5305151
• Product Code: EZY
• UDI-Device Identifier: 00878953005652
• UDI-Public: (01)00878953005652(17)261126(10)1100636372
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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 Model Number: 720157-01
• Device Catalogue Number: 720157-01
• Device Lot Number: 1100636372
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male