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

Model Number	72400098
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.D4.Concomitant product udi for cuff is (b)(4) and for balloon is (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced cutaneous erosion and exposure of the tubing in the inguinal region, along with a cutaneous fistula revealing the tubing.As a result, the pump was explanted, while the balloon and cuff were left in place.No further patient complications were reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced cutaneous erosion and exposure of the tubing in the inguinal region, along with a cutaneous fistula revealing the tubing.As a result, the pump was explanted, while the balloon and cuff were left in place.No further patient complications were reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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.A risk review was completed and confirmed that the event of erosion, extrusion, and fistula was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100650854.Model/catalog description: balloon.Unique identifier (udi) # (b)(4).Model number/catalog number: 72400166.Serial number: n/a.Batch/lot number: 1100474724.Model/catalog description: cuff.Unique identifier (udi) # (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
• MDR Report Key: 24321486
• Report Number: 2124215-2026-07920
• Device Sequence Number: 15821600
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)300824(10)1100783942
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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 Model Number: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1100783942
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 08/25/2025
• 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: 1100650854; BALLOON UPN: 72400024, LOT: 1100650854; CUFF UPN: 72400166, LOT: 1100474724,; CUFF UPN: 72400166, LOT: 1100474724,
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown