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

Model Number	72400098
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) pump was mispositioned in the patient's scrotum.It was believed that due to the patient's size, placing the pump lower would allow the patient to better access the pump.The patient later reported difficulty accessing the pump due to its location.As a result, the pump was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) pump was mispositioned in the patient's scrotum.It was believed that due to the patient's size, placing the pump lower would allow the patient to better access the pump.The patient later reported difficulty accessing the pump due to its location.As a result, the pump was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72400024, serial number: n/a, batch/lot number: 1100687795, model/catalog description: balloon fgs 61-70 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: 72400160, serial number: n/a, batch/lot number: 1100817998, model/catalog description: belt cuff fgs 4.0 cm, unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The pump was visually and microscopically inspected, and a leakage and functional tests were performed.As a result of these tests, no anomalies or damage were identified.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 event of difficult to press and malposition of device 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 and analysis results, cause not established was assigned to this investigation.Model number/catalog number: 72400024, batch/lot number: 1100687795, model/catalog description: balloon fgs 61-70 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: 72400160, batch/lot number: 1100817998, model/catalog description: belt cuff fgs 4.0 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: 50217668
• Report Number: 2124215-2026-43115
• Device Sequence Number: 10584635
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)301019(10)1100817899
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/17/2026

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: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1100817899
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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 Age: 81 YR
• Patient Sex: Male