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

Model Number	72400165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930); Inflammation (1932); Urinary Retention (2119)
Date of Event	08/22/2025
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).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with acute urinary retention accompanied by pelvic pain.Laboratory tests revealed an inflammatory syndrome, and an abdominopelvic computed tomography scan showed findings suggestive of an infection.The aus was explanted, and the patient was treated with antibiotics.There were no additional patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for balloon:(b)(4).D4 unique identifier (udi) for pump: (b)(4).Upon receipt at our quality assurance laboratory, this aus cuff and pump underwent a thorough analysis.The components were visually and leak tested; and the pump was also functionally tested.It was found to had tool mark and sharp instrument damage along the lateral edge of the cuff shell towards the cuff tab.Cuff passed leakage test.Regarding the pump, it passed visual inspection and leakage test; however, it did not pass the functional testing as the output pressure was measured below specification.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Additionally, the functional problems found in the pump could affect the device performance.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with acute urinary retention accompanied by pelvic pain.Laboratory tests revealed an inflammatory syndrome, and an abdominopelvic computed tomography scan showed findings suggestive of an infection.The aus was explanted, and the patient was treated with antibiotics.There were no additional 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: 23092118
• Report Number: 2124215-2025-65719
• Device Sequence Number: 18770888
• Product Code: EZY
• UDI-Device Identifier: 00878953000763
• UDI-Public: (01)00878953000763(17)280213(10)1100259447
• 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 Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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 Model Number: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 1100259447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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 1100682711; BALLOON: UPN 72400024 / LOT 1100682711; PUMP: UPN 72400098 / LOT 1100687343; PUMP: UPN 72400098 / LOT 1100687343
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female