MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	720133-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with an infection.The aus was explanted.There were no additional patient complications reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with an infection.The aus was explanted.There were no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the artificial urinary sphincter (aus) at our quality assurance laboratory, the returned components underwent a thorough analysis.Examination of the cuff found the shell was worn from wear at a fold.The component did pass the leak test performed.The balloon and pump did not show any signs of abnormalities and passed the leak testing performed.The balloon also passed the functional testing performed as well.Based on this information, the reported clinical observation of infection is a known inherent risk with the device.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with an infection.The aus was explanted.There were no additional patient complications reported.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• 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: 19098584
• Report Number: 2124215-2024-22417
• Device Sequence Number: 18096059
• Product Code: EZY
• UDI-Device Identifier: 00878953005461
• UDI-Public: 00878953005461
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• 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): 07/22/2024

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: 04/26/2024
• Device Model Number: 720133-01
• Device Catalogue Number: 720133-01
• Device Lot Number: 1100124734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 07/02/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 04/30/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UPN 72400024 - LOT 1100309077 - BALLOON; UPN 72400024 - LOT 1100309077 - BALLOON; UPN 72400024 - LOT 1100309077 - BALLOON; UPN 72404127 - LOT 1100324481 - CONTROL PUMP; UPN 72404127 - LOT 1100324481 - CONTROL PUMP; UPN 72404127 - LOT 1100324481 - CONTROL PUMP
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown