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

Model Number	72400161
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for pump: (b)(4).D4 unique identifier (udi) for balloon: (b)(4).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.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not performing as expected.Two weeks later a revision surgery was performed, upon examination crack in the cuff was found.The cuff was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not performing as expected.Two weeks later a revision surgery was performed, upon examination crack in the cuff was found.The cuff was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for pump: (b)(4).D4 unique identifier (udi) for balloon: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The cuff was visually inspected.It was found to have a fold along the lateral edge of the cuff shell towards the adapter.Cuff passed leakage test.Tubing passed visual inspection and leakage test.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

• 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: 23760816
• Report Number: 2124215-2025-89956
• Device Sequence Number: 10170525
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)271211(10)1100232710
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 1100232710
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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 1100259121; BALLOON: UPN 72400024 / LOT 1100259121; PUMP: UPN 72400098 / LOT 1100256627; PUMP: UPN 72400098 / LOT 1100256627
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male