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	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced recurrent urinary incontinence.It was determined that the cuff was too large for the patient.A surgical procedure was performed to downsize the cuff.No further patient complications were reported.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced recurrent urinary incontinence.It was determined that the cuff was too large for the patient.A surgical procedure was performed to downsize the cuff.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404127.Serial number: n/a.Batch/lot number: 1100701246.Model/catalog description: control pump fgs iz.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100720950.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Model number/catalog number: 72404127.Serial number: n/a.Batch/lot number: 1100701246.Model/catalog description: control pump fgs iz.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100720950.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (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.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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 event of urinary incontinence and inadequate cuff size/loose cuff was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.

• 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: 50209649
• Report Number: 2124215-2026-42894
• Device Sequence Number: 21304049
• Product Code: EZY
• UDI-Device Identifier: 00878953003108
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 09/15/2026

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: 1100666600
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 01/29/2025
• 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: 65 YR
• Patient Sex: Male