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

Model Number	72400170
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was manufactured prior to the udi regulation: this product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom is a known risk associated with implant of these devices as indicated in the instructions for use.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) experience recurring incontinence due to the device not working properly.A surgical procedure was performed to explant the device and replaced with a new aus.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experience recurring incontinence due to the device not working properly.A surgical procedure was performed to explant the device and replaced with a new aus.No additional patient complications were reported.
Additional Manufacturer Narrative
Product was manufactured prior to the udi regulation: this product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.Upon receipt at the quality assurance laboratory, the returned components underwent a thorough analysis.The cuff was visually inspected and leak tested.Visual inspection revealed wear on the cuff shell at the corner of a fold and scaling on the cuff backing.The leakage test indicated fluid loss due to a tear along the lateral edge of the cuff shell near the cuff tab.The pump was visually inspected, leaked and functionally tested.Visual inspection showed scaling on the pump and tubing worn down to the filament.Both leakage and functional tests passed.The balloon was visually inspected, leak tested, and functionally tested, with all tests passing and no damage or abnormalities identified.Based on the available information and analysis results, the wear on the cuff shell and the fluid loss caused by the tear could have contributed to the reported clinical observation of device mechanical issue.The reported patient symptom is a known risk associated with implant of these device as indicated in the instructions for use (ifu).

• 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: 23101172
• Report Number: 2124215-2025-65463
• Device Sequence Number: 8617680
• Product Code: EZY
• UDI-Device Identifier: 00878953000800
• UDI-Public: (01)00878953000800
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• 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): 01/07/2026

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 Model Number: 72400170
• Device Catalogue Number: 72400170
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 87 YR
• Patient Sex: Female