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

Model Number	72404127
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) experienced complete extrusion of the pump through the scrotal skin, resulting in the pump being completely outside the body.A surgical procedure was performed during which the aus was explanted.It was decided to allow the patient to recover prior to determining whether reimplantation would be appropriate.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404131.Serial number: n/a.Batch/lot number: 1100916926.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: 1100435226.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) experienced complete extrusion of the pump through the scrotal skin, resulting in the pump being completely outside the body.A surgical procedure was performed during which the aus was explanted.It was decided to allow the patient to recover prior to determining whether reimplantation would be appropriate.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404131 serial number: n/a batch/lot number: 1100916926 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: 1100435226 model/catalog description: balloon fgs 61-70 cm unique identifier (udi) #: (b)(4).The device was not available for analysis; therefore, a physical examination of the product could not be performed.However, a review of the provided media was conducted, and the reported allegations were confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications prior to distribution.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 extrusion and migration was 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, a conclusion code of adverse event related to patient condition was assigned to this investigation, as the patient's condition, disease, or anatomy is demonstrably responsible for the adverse events of extrusion and migration and use of the device has neither caused nor otherwise influenced the adverse events.

• 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: 25841620
• Report Number: 2124215-2026-38212
• Device Sequence Number: 13189747
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: (01)00878953003078(17)270904(10)1100788862
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 1100788862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 09/04/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male