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

Model Number	72404127
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) was unable to properly activate the device.Troubleshooting maneuvers were performed in the office; however, they were unsuccessful in resolving the issue.Therefore, a surgical procedure was performed, during which it was determined that the pump was not cycling properly, preventing the device from functioning as intended.During the same procedure, hardening was observed in the area surrounding the pump, raising suspicion of an infectious process, particularly given the patient's history of diabetes.As a result, the decision was made to explant the aus in its entirety.Later, the surgical re implantation was performed, a new aus was implanted.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant products implanted at time of event: model number/catalog number: 72400164 serial number: n/a batch/lot number: 1100536960 model/catalog description: belt cuff fgs 6.0 cm unique identifier (udi): (b)(4) model number/catalog number: 72400024 serial number: n/a batch/lot number: 1000022114 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: 50351081
• Report Number: 2124215-2026-44902
• Device Sequence Number: 10190182
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: (01)00878953003078(17)270429(10)1100720092
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/17/2026

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: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1100720092
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 04/29/2025
• 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: 77 YR
• Patient Sex: Male