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	Urinary Incontinence (4572)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this artificial urinary sphincter (aus) experienced recurrent incontinence approximately six months post-implantation and three months after device activation.The patient reported that the device was no longer functioning properly and that symptoms of incontinence had returned.During a clinical examination, it was determined that there was a potential device-related issue, and revision surgery was scheduled to investigate the cause.During the surgical procedure, after the pump was exposed, it was observed that saline was not returning from the pressure-regulating balloon to the pump as expected.Troubleshooting was performed; however, no cause could be identified.The saline volume within the balloon was measured and found to be 23 cc, consistent with the volume documented during the original implantation procedure.Based on this finding, it was initially concluded that the balloon was functioning properly.To minimize unnecessary component replacement, only the pump was explanted and replaced.The newly implanted pump was connected to the existing system, and the aus was tested through three complete cycles.The system functioned normally during all three cycles, suggesting that the issue was likely related to the original pump.Therefore, no additional components, including the cuff or pressure-regulating balloon, were explanted.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant products implanted at the time of the event: model number/catalog number: 72404132.Serial number: n/a.Batch/lot number: 1100475240.Model/catalog description: belt cuff fgs 5.0 cm iz.Unique identifier (udi) #: ((b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100712529.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: 50806220
• Report Number: 2124215-2026-49739
• Device Sequence Number: 8543099
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 1100719383
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 04/28/2025
• 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: 64 YR
• Patient Sex: Male