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

Model Number	72404133
Medical Device Problem Codes	Nonstandard Device (1420); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an artificial urinary sphincter (aus) surgery due to unspecified reasons.No additional information was reported.The device was returned and the device analysis revealed that this device did not pass all testing.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The balloon was visually inspected and leak tested.Visual inspection revealed a tear from fatigue at the balloon/adapter junction.Leak testing revealed a leak in the balloon due to pinhole from fatigue.The pump was visually inspected, leak and functional tested.Visual inspection did not reveal any anomalies in the pump.The pump passed the leak and functional test.The belt cuff fgs 5.5 cm iz is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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 finding of fluid loss from fatigue 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 analysis results, the leak due to pinhole from fatigue identified in the balloon could have caused or contributed to the reported event, therefore, the cause traced to component failure was assigned to this investigation.Model number/catalog number: 72400024 serial number: n/a batch/lot number: 1100570602 model/catalog description: balloon fgs 61-70 cm unique identifier (udi) # (b)(4).Model number/catalog number: 72404127 serial number: n/a batch/lot number: 1100635375 model/catalog description: control pump fgs iz 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: 25600515
• Report Number: 2124215-2026-33435
• Device Sequence Number: 18622423
• Product Code: EZY
• UDI-Device Identifier: 00878953003115
• UDI-Public: (01)00878953003115(17)260102(10)1100419341
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 01/02/2026
• Device Model Number: 72404133
• Device Catalogue Number: 72404133
• Device Lot Number: 1100419341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male