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	09/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).Concomitant product udi for pump is (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 the patient visited the hospital because his artificial urinary sphincter (aus) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a crack was identified in the cuff connecting tube.All components were explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).Concomitant product udi for pump is (b)(4).Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected and leak tested.Visual inspection revealed that the cuff had folds.The cuff passed the leakage test, and no fluid loss was identified.The pump was visually inspected, leak tested, and functionally tested.Visual inspection revealed that the pump tubing had a hole from fatigue below the adaptor junction, and the tubing showed wear consistent with fatigue.The pump failed the leakage test due to fluid loss from fatigue.Prior to functional testing, the pump tubing with the hole from fatigue was trimmed.Functional testing revealed that the pump failed the resistor flow rate test with no fluid output volume, which is below specification.The balloon was visually inspected.Visual inspection revealed that the balloon had folds in the shell and a hole consistent with sharp instrument damage.Due to the identified sharp instrument damage, the balloon was not leak tested or functionally tested.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.Based on the available test results and investigation, product analysis was able to confirm a leak in the pump tubing resulting from fatigue, which supports the reported mechanical issue and hole/perforation.The sharp instrument damage observed on the balloon is considered a secondary finding and was likely introduced during explant, and the cuff findings did not demonstrate leakage or functional impairment.Therefore, this investigation is assigned a most probable conclusion code of cause traced to component failure, as the pump tubing leak from fatigue was identified during functional testing and determined to be the most probable cause of the complaint.
Event or Problem Description
It was reported that the patient visited the hospital because his artificial urinary sphincter (aus) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a crack was identified in the cuff connecting tube.All components were explanted and replaced.There were no patient complications reported.

• 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: 23369264
• Report Number: 2124215-2025-75806
• Device Sequence Number: 21362806
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)210401(10)128841001
• 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: 2016
• 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): 12/29/2025

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 Expiration Date: 04/01/2021
• Device Model Number: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 0128841001
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: LOT:137206016 UPN:72400098. PUMP; LOT:137206016 UPN:72400098. PUMP; LOT:141993017 UPN:72400024. BALLOON; LOT:141993017 UPN:72400024. BALLOON
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male