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

Model Number	72400161
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's artificial urinary sphincter (aus) was not functioning properly.The patient experienced recurrent urinary incontinence and presented with bladder lesions.A surgical procedure was performed, during which the aus was completely replaced.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1000133224.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400098.Serial number: n/a.Batch/lot number: 1000152996.Model/catalog description: control pump fgs.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.The reported patient symptoms are 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: 25461076
• Report Number: 2124215-2026-31028
• Device Sequence Number: 12938695
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)230507(10)1000103487
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 05/07/2023
• Device Model Number: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 1000103487
• 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: 05/18/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/07/2026
• Date Device Manufactured: 05/08/2018
• 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 Sex: Unknown