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

Model Number	72400023
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Hernia (2240)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that, during the implant procedure of an artificial urinary sphincter device, the balloon became entangled into the patient inguinal hernia.A hernia repair surgery was begin considered by the physicians.No additional information was available at the time.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product specific information.If additional details become available, a supplemental report will be submitted.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms of hernia and extrusion are known risks associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that, during the implantation of an artificial urinary sphincter aus device, the balloon migrated and prolapsed into the inguinal region, presenting as an inguinal hernia.A surgical procedure for the hernia repair was scheduled.No further patient complications were reported.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product specific information.If additional details become available, a supplemental report will be submitted.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported allegations of hernia, extrusion and migration are known risks associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that, during the implantation of an artificial urinary sphincter aus device, the balloon migrated and prolapsed into the inguinal region, presenting as an inguinal hernia.A surgical procedure for the hernia repair was scheduled.No further patient complications were 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: 22198061
• Report Number: 2124215-2025-38300
• Device Sequence Number: 18576851
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: (01)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
• 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): 08/25/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72400023
• Device Catalogue Number: 72400023
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/30/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/25/2025
• 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: Other
• Patient Sex: Unknown