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

Model Number	72400162
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump 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's artificial urinary sphincter (aus) was not functioning properly.During the surgical procedure, a crack was identified in the cuff connecting tube.The cuff was replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The cuff was visually inspected and leak tested; both tests passed, and no damage or abnormalities were observed.The black suture tubing was also visually inspected and leak tested.Visual examination showed that it was returned with a straight quick connect window connector attached, and the suture tubing exhibited wear down to the filament.The leak test passed as well.Based on the available information and analysis results, the reported clinical observations of device mechanical issue and tube hole/perforation could not be confirmed.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.
Event or Problem Description
It was reported that the patient's artificial urinary sphincter (aus) was not functioning properly.During the surgical procedure, a crack was identified in the cuff connecting tube.The cuff was replaced.No patient complications were 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: 23686462
• Report Number: 2124215-2025-86177
• Device Sequence Number: 13199909
• Product Code: EZY
• UDI-Device Identifier: 00878953000732
• UDI-Public: (01)00878953000732(17)290515(10)1100513457
• 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: 2025
• 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): 01/22/2026

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: 72400162
• Device Catalogue Number: 72400162
• Device Lot Number: 1100513457
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: UPN: 72400024 / LOT: 1100634460; BALLOON: UPN: 72400024 / LOT: 1100634460; PUMP: UPN: 72400098 / LOT: 1100598036; PUMP: UPN: 72400098 / LOT: 1100598036
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male