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

Model Number	72404127
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Urinary Incontinence (4572)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent urinary incontinence.During a surgical procedure, it was identified that the pump tubing had eroded through the urethral skin.As a result, the pump and balloon were explanted.The 4.5 cm cuff was left in situ to serve as a placeholder on the urethra.Subsequently, a second surgical procedure was performed during which the cuff was explanted, and a new aus system was implanted.No additional patient complications were reported.
Additional Manufacturer Narrative
The cuff was explanted, and a new artificial urinary sphincter (aus) was implanted during a surgical procedure performed on (b)(6) 2026.Despite good faith efforts, the explant dates of the pump and balloon components were not provided.If additional details become available, a supplemental report will be submitted.Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100534654.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404131.Serial number: n/a.Batch/lot number: 1100470720.Model/catalog description: belt cuff fgs 4.5 cm iz.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: 50141966
• Report Number: 2124215-2026-41895
• Device Sequence Number: 10731359
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: (01)00878953003078(17)260517(10)1100514853
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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 Expiration Date: 05/17/2026
• Device Model Number: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1100514853
• 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: 07/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 05/17/2024
• 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 Age: 68 YR
• Patient Sex: Unknown