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

Model Number	72404134
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Migration (4003)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404127, serial number: n/a, batch/lot number: 1100626257, model/catalog description: control pump fgs iz, unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024, serial number: n/a, batch/lot number: 1100599955, model/catalog description: balloon fgs 61-70 cm, 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 symptom is known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) experienced recurrent urinary incontinence.During surgical evaluation, the balloon component was found to have herniated out of the space of retzius through the original incision site in the lower abdomen, where it had been implanted.This displacement prevented the device from functioning properly.The balloon was replaced, and further assessment showed that the migration had also prevented the cuff from fully occluding the urethra.Consequently, the cuff was replaced with a smaller size, reduced from 6.0 cm to 4.5 cm.It was mentioned that the previous surgeon determined that the 6.0 cm cuff provided a better fit for the patient.No additional patient complications were reported.

• 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: 24592255
• Report Number: 2124215-2026-14018
• Device Sequence Number: 8933065
• Product Code: EZY
• UDI-Device Identifier: 00878953003122
• UDI-Public: (01)00878953003122(17)260618(10)1100533682
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/18/2026
• Device Model Number: 72404134
• Device Catalogue Number: 72404134
• Device Lot Number: 1100533682
• 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: 02/12/2026
• Initial Report FDA Received Date: 03/13/2026
• Date Device Manufactured: 06/18/2024
• 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: 79 YR
• Patient Sex: Unknown