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

Model Number	72400168
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Decrease in Pressure (1490)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Urinary Incontinence (4572)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent urinary incontinence and lower urinary tract infections for several months.Endoscopic examination revealed a non-occlusive cuff, and abdominal ultrasound demonstrated a progressive and steady decrease in balloon volume.These findings are consistent with a probable microleak within the system.The aus was completely removed and replaced.No additional information was provided.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The patient symptoms are a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent urinary incontinence and lower urinary tract infections for several months.Endoscopic examination revealed a non-occlusive cuff, and abdominal ultrasound demonstrated a progressive and steady decrease in balloon volume.These findings are consistent with a probable micro leak within the system.The aus was completely removed and replaced.No additional information was provided.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) review was unable to be performed as the lot number was not provided.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.Based on the information available, the cause that contributed to the reported event cannot be excluded as a device problem.The patient symptoms are known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.

• 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: 24262118
• Report Number: 2124215-2026-06508
• Device Sequence Number: 15846696
• Product Code: EZY
• UDI-Device Identifier: 00878953000794
• UDI-Public: (01)00878953000794(17)140402(10)590140005
• 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: 2012
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 04/02/2014
• Device Model Number: 72400168
• Device Catalogue Number: 72400168
• Device Lot Number: 590140005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 02/25/2009
• 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: 647141013; BALLOON: UPN: 72400024 / LOT: 647141013; PUMP: UPN: 72400098 / LOT: 644545017; PUMP: UPN: 72400098 / LOT: 644545017
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown