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

Model Number	72404127
Medical Device Problem Codes	Mechanical Problem (1384); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	08/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient stated the artificial urinary sphincter (aus) device stopped functioning and that repeated attempts to cycle the pump did not open the cuff, resulting in an inability to empty the bladder.The patient reported experiencing urinary retention.The patient was advised to seek immediate evaluation by a physician and was provided contact information for local urologists.No revision procedure was reported at the time of the complaint.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404131.Serial number: n/a.Batch/lot number: 1000479872.Model/catalog description: belt cuff fgs 4.5 cm iz unique identifier (udi) #:(b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1000503335.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: 50693479
• Report Number: 2124215-2026-48176
• Device Sequence Number: 17624212
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: (01)00878953003078(17)210217(10)1000397282
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 02/17/2021
• Device Model Number: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1000397282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 02/18/2020
• 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: 88 YR
• Patient Sex: Male