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

Model Number	72400166
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of urinary incontinence is a known risk associated with implant of these device 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.D4.Concomitant product udi for pump is (b)(4) and for balloon is (b)(4).
Event or Problem Description
It was reported that the patient with an implanted artificial urinary sphincter (aus) experienced recurrent urinary incontinence.It was also noted that the device was not functioning.As a result, the aus was explanted and replaced.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The pump was visually inspected, functionally tested, and leak tested.Visual inspection revealed contamination inside the pump, which prevented functional testing.Additional observations included scaling at the pump and adaptor junction and pump tubing worn down to the filament.No leaks were identified.The balloon was visually inspected, functionally tested, and leak tested.Visual inspection revealed pinholes consistent with sharp instrument damage, as well as scaling and folds.The balloon adaptor junction also exhibited scaling.Leaks were detected at the pinholes, preventing functional testing.The cuff was visually inspected and leak tested.Observations included folds and scaling on the backing.A tear caused by tool/sharp instrument damage was identified along the lateral edge of the cuff shell toward the cuff tab, resulting in fluid loss.The reported patient symptom of urinary incontinence is a known risk associated with implantation of this device, as indicated in the instructions for use (ifu).Based on the available information and analysis results, the sharp instrument damage found on the device is considered a secondary failure; therefore, the allegation of a mechanical issue could not be confirmed.D4.Concomitant product udi for pump is (b)(4) and for balloon is (b)(4).
Event or Problem Description
It was reported that the patient with an implanted artificial urinary sphincter (aus) experienced recurrent urinary incontinence.It was also noted that the device was not functioning.As a result, the aus was explanted and replaced.No further 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: 23431681
• Report Number: 2124215-2025-76331
• Device Sequence Number: 21281559
• Product Code: EZY
• UDI-Device Identifier: 00878953000770
• UDI-Public: (01)00878953000770(17)100421(10)415844002
• 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: 2006
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 04/21/2010
• Device Model Number: 72400166
• Device Catalogue Number: 72400166
• Device Lot Number: 415844002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/13/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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 Sex: Unknown