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

Model Number	72404132
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced recurring incontinence.A surgical procedure was performed, during which the physician determined that the original cuff size was too large.Therefore, the cuff was downsized.No further patient complications were reported.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced recurring incontinence.A surgical procedure was performed, during which the physician determined that the original cuff size was too large.Therefore, the cuff was downsized.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72400024, batch/lot number: 1100598344, model/catalog description: balloon fgs 61-70 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: 72404127, batch/lot number: 1100820955, model/catalog description: control pump fgs iz, unique identifier (udi) #: (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications prior to distribution.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.A risk review was completed and confirmed that the events of urinary incontinence and inadequate cuff size/loose cuff were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported issues with the cuff length too long may have been due to a potential measurement error during the initial procedure.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Additional Manufacturer Narrative
Model number/catalog number: 72400024 serial number: n/a batch/lot number: 1100598344 model/catalog description: balloon fgs 61-70 cm unique identifier (udi) #: (b)(4) model number/catalog number: 72404127 serial number: n/a batch/lot number: 1100820955 model/catalog description: control pump fgs iz 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: 50245658
• Report Number: 2124215-2026-43626
• Device Sequence Number: 10070787
• Product Code: EZY
• UDI-Device Identifier: 00878953003108
• UDI-Public: (01)00878953003108(17)271013(10)1100813774
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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 Model Number: 72404132
• Device Catalogue Number: 72404132
• Device Lot Number: 1100813774
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 10/13/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male