MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device incontinence mechanical/hydraulic

Model Number	72404131
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring urinary incontinence.A surgical procedure was performed to fully replaced the aus.It was reported that the probable cause was device not functioning properly, possibly due to the cuff originally being too large.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring urinary incontinence.A surgical procedure was performed to fully replaced the aus.It was reported that the probable cause was device not functioning properly, possibly due to the cuff originally being too large.No additional information was provided.
Additional Manufacturer Narrative
Concomitant products implanted at time of event: model number/catalog number: 72404127.Serial number: n/a.Batch/lot number: 1100427337.Model/catalog description: control pump fgs iz.Unique identifier (udi): (b)(4).
Additional Manufacturer Narrative
Concomitant products implanted at time of event: model number/catalog number: 72404127 serial number: n/a batch/lot number: 1100427337 model/catalog description: control pump fgs iz unique identifier (udi): (b)(4) model number/catalog number: 72400024 serial number: n/a batch/lot number: 1100480436 model/catalog description: balloon fgs 61-70 cm unique identifier (udi): (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: 50333746
• Report Number: 2124215-2026-44727
• Device Sequence Number: 5624803
• Product Code: EZY
• UDI-Device Identifier: 00878953003092
• UDI-Public: (01)00878953003092(17)251227(10)1100418426
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• 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): 09/24/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/27/2025
• Device Model Number: 72404131
• Device Catalogue Number: 72404131
• Device Lot Number: 1100418426
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/28/2026; 08/31/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 08/27/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown