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

Model Number	72404134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with sub-cuff erosion of the urethra.A surgical procedure was performed during which the device was explanted.No further patient complications were reported.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for balloon is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Tissue erosion is acknowledged within the dfu and is not related to off-label use or failure to follow instructions.The reported patient symptoms of erosion is a known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with sub cuff erosion of the urethra.A surgical procedure was performed during which the device was explanted.The patient reported experiencing continuous pain since the procedure.No additional information was provided.
Additional Manufacturer Narrative
Model number/catalog number: 72404127 serial number: n/a batch/lot number: 1100768172 model/catalog description: control pump fgs iz unique identifier (udi) #: ((b)(4).Model number/catalog number: 72400624 serial number: n/a batch/lot number: 1100767750 model/catalog description: balloon fgs 61-70 cm unique identifier (udi) #:(b)(4).Correction to field c2/d10: concomitant product/therapy the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Tissue erosion and pain are acknowledged within the instructions for use (ifu) and are not related to off-label use or failure to follow instructions.The reported patient symptoms of tissue erosion and pain are known risk associated with this device type and indicated as such in the instructions for use.

• 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: 23835162
• Report Number: 2124215-2025-88079
• Device Sequence Number: 14722785
• Product Code: EZY
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 05/07/2026
• Device Model Number: 72404134
• Device Catalogue Number: 72404134
• Device Lot Number: 1100508300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 05/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON LOT 1100767750, UPN 72400624; BALLOON LOT 1100767750, UPN 72400624.; PUMP LOT 1100768172, UPN 72404127; PUMP LOT 1100768172, UPN 72404127.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male