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

Model Number	72400098
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Prolapse (2475); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) presented for a follow-up session, during which a cystoscopy was performed.The examination revealed no device-related issues.Bladder filling was normal, and no abnormalities or signs of erosion were observed during vaginal endoscopy.Vaginal examination showed no suspicious findings, and there was no leakage during coughing or straining.A grade 1 rectocele was noted, without cystocele, and palpation of the pump site elicited no pain.Despite this, the patient had been experiencing pain near the pump for several weeks.One week prior to admission, edema and inflammation developed at the site, prompting her attending physician to initiate antibiotic therapy, which initially led to clinical improvement.However, the day before hospitalization, the patient observed that the pump had exteriorized through the right labia majora.Clinical examination confirmed the exteriorization of the pump through the right labia majora, with mild skin inflammation and no palpable renitent mass.The patient was stable.Laboratory findings indicated signs of infection.A localized infection at the pump site, complicated by exteriorization of the device, was diagnosed.As a result, the device was explanted.No further complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4).
Event or Problem Description
It was reported that the patient with an artificial urinary sphincter (aus) presented for a follow-up session, during which a cystoscopy was performed.The examination revealed no device-related issues.Bladder filling was normal, and no abnormalities or signs of erosion were observed during vaginal endoscopy.Vaginal examination showed no suspicious findings, and there was no leakage during coughing or straining.A grade 1 rectocele was noted, without cystocele, and palpation of the pump site elicited no pain.Despite this, the patient had been experiencing pain near the pump for several weeks.One week prior to admission, edema and inflammation developed at the site, prompting her attending physician to initiate antibiotic therapy, which initially led to clinical improvement.However, the day before hospitalization, the patient observed that the pump had exteriorized through the right labia majora.Clinical examination confirmed the exteriorization of the pump through the right labia majora, with mild skin inflammation and no palpable renitent mass.The patient was stable.Laboratory findings indicated signs of infection.A localized infection at the pump site, complicated by exteriorization of the device, was diagnosed.As a result, the device was explanted.No further complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4) and 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.The reported patient symptoms are known risks 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: 23597929
• Report Number: 2124215-2025-81589
• Device Sequence Number: 21166471
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)290210(10)1100448269
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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 Model Number: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1100448269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/07/2026
• Date Device Manufactured: 02/12/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown