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

Model Number	72404133
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
Date of Event	07/01/2025
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 breakthrough incontinence and the urethra had atrophied.The physician removed the device through extraction surgery, and there were no further signs or symptoms reported.
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.Urethral atrophy is acknowledged within the dfu and is 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 atrophy.Recurrent incontinence is 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.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) implant device was experiencing recurring breakthrough incontinence and the urethra had atrophied.The physician stated that the old aus device was no longer working.The size cuff that was explanted was a size 5.5 cm cuff, and the cuff that was implanted by the physician was 4.0 cm.The physician felt that the cuff initially placed was in the correct location.The physician removed and replaced the entire device through replacement surgery, and there were no further patient complications reported.
Additional Manufacturer Narrative
B3: date is unknown, so estimated date was entered.C2/d10: 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 or visual analysis of the product could be performed.Urethral atrophy is acknowledged within the dfu and is 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 atrophy.Recurrent incontinence is 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.The reported patient symptoms 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 fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086521217
• MDR Report Key: 23863086
• Report Number: 2124215-2025-92247
• Device Sequence Number: 9409573
• Product Code: EZY
• UDI-Device Identifier: 00878953003115
• UDI-Public: (01)00878953003115(17)210402(10)1000423720
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/27/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/02/2021
• Device Model Number: 72404133
• Device Catalogue Number: 72404133
• Device Lot Number: 1000423720
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/27/2026
• Date Device Manufactured: 04/02/2020
• 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: LOT: 1000401565 UPN 72400024; BALLOON: LOT: 1000401565 UPN 72400024; PUMP: LOT: 1000435992 UPN 72404127; PUMP: LOT: 1000435992 UPN 72404127
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male