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

Model Number	72404135
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) implant device was experiencing recurring incontinence.The physician believes the original cuff was too large and loose around the urethra, and this was what contributed to the recurring incontinence.A revision surgery was performed at which time the original cuff was explanted and a new cuff was implanted.There were no further patient complications.
Additional Manufacturer Narrative
D10: concomitant product udi for pump is (b)(4).D10: concomitant product udi for balloon is (b)(4).H6: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Recurrent incontinence, and positional incontinence are acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 800 implantation and to prevent altered therapeutic response.Improperly sized cuff and incorrect tubing lengths are acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu instructs to remove improperly sized cuff.Resize the urethra with the cuff sizer and implant the proper size, if the cuff is too tight or too loose.The dfu also states, cut the tubing length to fit the patients anatomy with clean, straight scissors, making sure the cut end is square.The dfu provides guidance and instruction to achieve successful ams 800 implantation and to prevent size related complications.The reported patient symptom(s) are known risk associated with this device type and indicated as such 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 ; 5086521217
• MDR Report Key: 23882590
• Report Number: 2124215-2025-92786
• Device Sequence Number: 11954887
• Product Code: EZY
• UDI-Device Identifier: 00878953003139
• UDI-Public: (01)00878953003139(17)261206(10)1100640756
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 12/23/2025

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: 72404135
• Device Catalogue Number: 72404135
• Device Lot Number: 1100640756
• 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: 11/28/2025
• Initial Report FDA Received Date: 12/23/2025
• Date Device Manufactured: 12/06/2024
• 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: LOT: 1100553485 UPN:72400024 BALLOON FGS 61-70 CM.; LOT: 1100672915 UPN: 72404127 CONTROL PUMP FGS IZ.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male