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

Model Number	72400023
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact event date was not available, therefore the date (b)(6) 2024 was used as estimate, as it was reported that the recurring incontinence started in 2024.The exact implant date was not available, therefore the date (b)(6) 2020 was used as estimate, as it was reported that the device was implanted 4 years ago.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring incontinence.In addition, the device was not working properly, and the pump was rigid.A computed tomography (ct) was performed, during which it was noted that the balloon was collapsed; therefore, the patient underwent a surgical intervention to remove and replace the aus.Upon explant, a total loss of fluid from the balloon and cuff was identified, while the pump was still retaining fluid.There were no patient complications reported.
Additional Manufacturer Narrative
The exact event date was not available, therefore the date (b)(6) 2024 was used as estimate, as it was reported that the recurring incontinence started in 2024.The exact implant date was not available, therefore the date (b)(6) 2020 was used as estimate, as it was reported that the device was implanted 4 years ago.Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The balloon was visually inspected, leak and functionally tested.No leaks were identified; however, the component exhibited folds and an output pressure above specifications.The cuff was visually inspected and tested for leaks.Wear at fold in its shell was noted, along with a leak and a hole also in its shell consistent with sharp instrument damage.The pump was visually inspected, leak and functionally tested, and it passed all testing.Based on the information available and analysis results, the balloon not passing functional evaluation could have caused or contributed to the reported clinical observations regarding that component.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurring incontinence.In addition, the device was not working properly, and the pump was rigid.A computed tomography (ct) was performed, during which it was noted that the balloon was collapsed; therefore, the patient underwent a surgical intervention to remove and replace the aus.Upon explant, a total loss of fluid from the balloon and cuff was identified, while the pump was still retaining fluid.There were no patient complications reported.

• 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: 21112289
• Report Number: 2124215-2024-83249
• Device Sequence Number: 7436746
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: 00878953000619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 02/13/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72400023
• Device Catalogue Number: 72400023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown