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

Model Number	72400023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for cuff is udi: (b)(4).Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was associated with recurring urinary incontinence.The cuff appeared to be functioning properly; however, the physician elected to replace the original pressure-regulating balloon (prb) with a higher pressure prb to improve continence.A surgical procedure was performed, and cystoscopy confirmed the implant looked appropriate.There were no further patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for cuff is udi: (b)(4).Concomitant product udi for pump is (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of incontinence 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 this artificial urinary sphincter (aus) was associated with recurring urinary incontinence.The cuff appeared to be functioning properly; however, the physician elected to replace the original pressure-regulating balloon (prb) with a higher pressure prb to improve continence.A surgical procedure was performed, and cystoscopy confirmed the implant looked appropriate.There were no further patient complications 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: 22311863
• Report Number: 2124215-2025-40533
• Device Sequence Number: 12998811
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: (01)00878953000619(17)290714(10)1100547494
• Combination Product (Y/N): N
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72400023
• Device Catalogue Number: 72400023
• Device Lot Number: 1100547494
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 07/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUFF. UPN: 72404130 LOT:1100500965; CUFF. UPN: 72404130 LOT:1100500965; PUMP. UPN:72404127 LOT:1100638284; PUMP. UPN:72404127 LOT:1100638284
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown