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

Model Number	72400098
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4) and for balloon (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring urinary incontinence.The device was not cycling properly.On (b)(6) 2025, a computed tomography showed that the pressure regulating balloon had a low volume.Urethrocystoscopy was used to identify the incomplete occlusion of the bulbar urethra at the site of implantation of the cuff.The aus is still implanted; a replacement surgery will be performed.No further patient complications reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring urinary incontinence.The device was not cycling properly.On (b)(6) 2025, a computed tomography showed that the pressure regulating balloon had a low volume.Urethrocystoscopy was used to identify the incomplete occlusion of the bulbar urethra at the site of implantation of the cuff.The aus is still implanted; a replacement surgery will be performed.No further patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4).

• 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: 22011849
• Report Number: 2124215-2025-30428
• Device Sequence Number: 7884042
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)280723(10)1100334886
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/13/2025

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: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1100334886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/13/2025
• Date Device Manufactured: 07/25/2023
• 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 1100474530.; BALLOON: UPN 72400024 LOT 1100474530.; CUFF: UPN 72400160 LOT 1100302864.; CUFF: UPN 72400160 LOT 1100302864.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male