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

Model Number	72404144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with an artificial urinary sphincter (aus) experienced pelvic trauma.During a clinic visit a cystoscopy procedure was performed during which it was discovered that there was erosion at the bulbous urethra, and a surgical procedure was performed in (b)(6) 2026, during which the cuff was explanted.An infection was confirmed later on which resulted in another surgical procedure in (b)(6) 2026, during which the pump and pressure regulating balloon (prb) were explanted.The physician was unable to identify the type of infection the patient had.The infection was treated with antibiotics.There were no device issues, the patient fully recovered, and there was no additional information was provided.
Additional Manufacturer Narrative
B3: date is unknown, so estimated date was entered.B6b: date is unknown, so estimated date was entered.Model number/catalog number: 72404127.Serial number: n/a.Batch/lot number: 1100650736.Model/catalog description: control pump fgs iz.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400025.Serial number: n/a.Batch/lot number: 1000441048.Model/catalog description: balloon fgs 71-80 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 ; +1(508)652-1217
• MDR Report Key: 50843404
• Report Number: 2124215-2026-50238
• Device Sequence Number: 21342038
• Product Code: EZY
• UDI-Device Identifier: 00878953003191
• UDI-Public: (01)00878953003191(17)250611(10)1100314662
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 09/28/2026

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: 06/11/2025
• Device Model Number: 72404144
• Device Catalogue Number: 72404144
• Device Lot Number: 1100314662
• 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: 09/02/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/21/2026
• Supplement Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 06/12/2023
• 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: 67 YR
• Patient Sex: Male