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

Model Number	72400166
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for pump: (b)(4).D4 unique identifier (udi) for balloon: (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) developed a chronic subclinical infection, which led to urethral erosion and migration of the cuff into the urethral lumen.The aus was explanted without replacement, and a healing period was indicated.No additional patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for pump: (b)(4).D4 unique identifier (udi) for balloon: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The cuff was visually inspected and leak testing.Cuff passed visual inspection and leakage test.Additionally, the pump passed visual inspection, leakage and functional test.Upon visual inspection, the balloon was found to have a tear on its shell, caused by damage from a tool or sharp instrument.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) developed a chronic subclinical infection, which led to urethral erosion and migration of the cuff into the urethral lumen.The aus was explanted without replacement, and a healing period was indicated.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: 22902675
• Report Number: 2124215-2025-59515
• Device Sequence Number: 21065860
• Product Code: EZY
• UDI-Device Identifier: 00878953000770
• UDI-Public: (01)00878953000770(17)281107(10)1100392757
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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 Model Number: 72400166
• Device Catalogue Number: 72400166
• Device Lot Number: 1100392757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: UPN 72400024 / LOT 1100464899.; BALLOON: UPN 72400024 / LOT 1100464899.; PUMP: UPN 72400098 / LOT 1100514602.; PUMP: UPN 72400098 / LOT 1100514602.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown