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

Model Number	72400161
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Urinary Incontinence (4572)
Date of Event	10/30/2025
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 pump 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 recurring incontinence, which was initially believed to be due to the device not working properly.However, during a cystoscopy examination, no device related issues were identified; instead, urethral erosion was observed.As a result, the aus was explanted.No further patient complications were reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring incontinence, which was initially believed to be due to the device not working properly.However, during a cystoscopy examination, no device related issues were identified; instead, urethral erosion was observed.As a result, the aus was explanted.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The balloon was visually inspected, functionally and leak tested.Visual inspection found that the balloon was non-spherical.The balloon did not pass the pressure test since the pressure was above specification.The balloon tubing had a fluid leak from sharp instrument, however, when the tube was trimmed down the balloon passed leakage test.The pump was visually inspected, functionally and leak tested.The visual inspection identified tears from sharp instrument in the pump tubing.The pump tubing had a leak due a tear from sharp instrument, however, when the tube was trimmed down the pump passed leakage test.The pump passed functional testing.The cuff was visually inspected, and leak tested.No anomalies were found with the cuff.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 and urinary incontinence was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available and the analysis results, the reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.There were no device allegations, however, the balloon not passing the functional test could affect product performance.Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100567229.Model/catalog description: balloon.Unique identifier (udi) # (b)(4).Model number/catalog number: 72400098.Serial number: n/a.Batch/lot number: 1100648479.Model/catalog description: pump.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: 23667612
• Report Number: 2124215-2025-85279
• Device Sequence Number: 12973206
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)270427(10)1100126015
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 1100126015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: BALLOON: UPN 72400024 LOT 1100567229; BALLOON: UPN 72400024 LOT 1100567229; PUMP: UPN 72400098 LOT 1100648479; PUMP: UPN 72400098 LOT 1100648479
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 71 KG