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

Model Number	72400164
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	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 presented to the clinic with recurring incontinence.The physician scoped the patient and cycled the artificial urinary sphincter (aus) implant device and determined that the cuff was not fully occluding.The physician removed and replaced the device through replacement surgery, and by measuring and downsizing the cuff to the correct measurement.There were no further signs or symptoms reported.
Additional Manufacturer Narrative
H6: 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 symptom is a known risk associated with this device type/procedure, and it is noted as such in the instructions for use.D10: concomitant product udi for pump is (b)(4).D10: concomitant product udi for balloon is (b)(4).
Event or Problem Description
It was reported that the patient presented to the clinic with recurring incontinence.The physician scoped the patient and cycled the artificial urinary sphincter (aus) implant device and determined that the cuff was not fully occluding.The most likely/suspected cause of the recurring incontinence was the cuff size was too large.The physician removed and replaced the device through replacement surgery, and by measuring and downsizing the cuff to the correct measurement to fit correctly.There were no further signs or symptoms reported.
Additional Manufacturer Narrative
H6: 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 symptom is a known risk associated with this device type/procedure, and it is noted as such in the instructions for use.D10: concomitant product udi for pump is (b)(4).D10: concomitant product udi for balloon is (b)(4).

• 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: 23595803
• Report Number: 2124215-2025-79573
• Device Sequence Number: 21166452
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: (01)00878953000756(17)270314(10)1100102400
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 12/16/2025

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: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 1100102400
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 03/15/2022
• 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: 1100558793 UPN 72400024 BALLOON FGS 61-70 CM; LOT: 1100558793 UPN 72400024 BALLOON FGS 61-70 CM; LOT: 1100688464 UPN 72404127 CONTROL PUMP FGS IZ; LOT: 1100688464 UPN 72404127 CONTROL PUMP FGS IZ
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male