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

Model Number	72400161
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product udi for cuff is (b)(4).Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced significant urinary incontinence after implantation.Imaging revealed that the pressure-regulating balloon contained less fluid than expected.The patient was determined to require replacement of the aus.There were no further patient complications reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced significant urinary incontinence after implantation.Imaging revealed that the pressure-regulating balloon contained less fluid than expected.The patient was determined to require replacement of the aus.There were no further patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).Concomitant product udi for pump is (b)(4).Correction to field b3: date of event.
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).Concomitant product udi for pump 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 with this artificial urinary sphincter (aus) experienced significant urinary incontinence after implantation.Imaging revealed that the pressure-regulating balloon contained less fluid than expected.A surgical procedure was performed in which the device was explanted and replaced.There were no further 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: 23184262
• Report Number: 2124215-2025-68805
• Device Sequence Number: 9146823
• Product Code: EZY
• UDI-Device Identifier: 00878953000732
• UDI-Public: (01)00878953000732(17)281018(10)1100380396
• 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: 2023
• 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,Followup
• Report Date (Section B): 11/18/2025

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: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 1100322051
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 10/24/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/08/2025; 11/18/2025
• Date Device Manufactured: 06/27/2023
• 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: 1100308396.; BALLOON: UPN: 72400024 / LOT: 1100308396.; CUFF: UPN: 72400161 / LOT: 1100322051.; PUMP: UPN: 72400098 / LOT: 1100308334.; PUMP: UPN: 72400098 / LOT: 1100308334.; PUMP: UPN: 72400098 / LOT: 1100308334.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male