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

Model Number	72400098
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	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for cuff is (b)(4).Concomitant product udi for balloon 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 went to the clinic because this artificial urinary sphincter (aus) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the pump connecting tube was identified.All the components were removed and replaced.The cause of crack in the connecting tube was not detailed by the hospital.There were no patient complications reported.
Event or Problem Description
It was reported that the patient went to the clinic because this artificial urinary sphincter (aus) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the pump connecting tube was identified.All the components were removed and replaced.The cause of crack in the connecting tube was not detailed by the hospital.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for cuff is (b)(4).Concomitant product udi for balloon is (b)(4).Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The pump was visually inspected, leak and functionally tested.Visual inspection revealed that the pump had worn down by the adaptor and pump block.The tubing was trim down to the adaptor and was not return for analysis.No leaks were found in the pump.The pump passed the functional test.The balloon was visually inspected and tested for leaks.Visual inspection revealed that the balloon was identified to be non-spherical and had folds in the shell.Balloon was identified to have a tear from fatigue between the shell and adaptor junction.The balloon had a leak due to a tear from fatigue between the shell and adaptor junction.The balloon was unable to be functionally tested due to the leak found.The cuff was visually inspected.Visual inspection revealed that the cuff tab was trimmed down and was not return for analysis.Cuff had a hole from sharp instrument damage along the lateral edge of the cuff shell towards the adapter.The leakage test was not performed due to a hole from sharp instrument damage.Based on the information available and analysis results, the reported allegations of mechanical issue and hole/perforated are unable to be confirmed.However, the balloon not passing the leakage test could affect the product performance.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.

• 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: 23877356
• Report Number: 2124215-2025-92615
• Device Sequence Number: 15865705
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)260307(10)1000540806
• 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: 2021
• 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): 02/16/2026

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: 03/07/2026
• Device Model Number: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1000540806
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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: 1000550546; BALLOON: UPN: 72400024 / LOT: 1000550546; CUFF: UPN: 72400160 / LOT: 1000396510; CUFF: UPN: 72400160 / LOT: 1000396510
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male