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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for balloon: (b)(4).D4 unique identifier (udi) for pump: (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 with this artificial urinary sphincter (aus) presented with device malfunction.The cuff remained open with no response to pumping attempts, and the sphincter was non-functional.Imaging showed the balloon had lost its typical shape.The aus was explanted and replaced.There is no additional information reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with device malfunction.The cuff remained open with no response to pumping attempts, and the sphincter was non-functional.Imaging showed the balloon had lost its typical shape.The aus was explanted and replaced.There is no additional information reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for balloon: (b)(4).D4 unique identifier (udi) for pump: ((b)(4).Updated impact codes h6.Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The cuff was identified to have folds it was observed to had a hole from wear at a corner of a fold in the lateral edge of the median cuff shell.Pump was microscopically inspected it was observed the pump tubing had worn to the filament.The pump passed leakage and functional test.Finally, the balloon was identified as non-spherical, and it was observed that the tubing was worn near the filament.Balloon passed leakage and functional test.Based on the information available and analysis results, the leak identified in the cuff could have caused or contributed to the reported clinical observation of mechanical problem.

• 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: 23873086
• Report Number: 2124215-2025-82492
• Device Sequence Number: 4605549
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: (01)00878953000725(17)220801(10)181971018
• 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: 2018
• 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): 03/03/2026

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 Expiration Date: 08/01/2022
• Device Model Number: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 0181971018
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2017
• 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 1000034262; BALLOON: UPN 72400024 / LOT 1000034262; PUMP: UPN 72400098 / LOT 1000049316; PUMP: UPN 72400098 / LOT 1000049316
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Unknown