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

Model Number	72404132
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) presented with a nonfunctioning device.A revision surgery was performed in which physician explanted the device.There were no patient complications.
Additional Manufacturer Narrative
Model number/catalog number: 72404127.Serial number: n/a.Batch/lot number: 1100717084.Model/catalog description: control pump fgs iz.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100723262.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.Mechanical issue is acknowledged within the instructions for use (ifu) and is not related to off-label use or failure to follow instructions.

• 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 ; +1(508)652-1217
• MDR Report Key: 25786566
• Report Number: 2124215-2026-37221
• Device Sequence Number: 10722053
• Product Code: EZY
• UDI-Device Identifier: 00878953003108
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 1100721774
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown