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

Model Number	72400160
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Decrease in Pressure (1490); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for balloon: (b)(4).D4 unique identifier (udi) for pump: (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 symptom(s) are 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 recurring incontinence.It was reported a sizing problem with the cuff.The aus was explanted and replaced.There is no additional information reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for balloon: (b)(4).D4 unique identifier (udi) for pump: (b)(4).Updated explant date d6b.Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The cuff was microscopically inspected and leak testing, and it passed both tests.The pump was microscopically inspected and underwent functional and leakage testing, and it successfully passed all tests.Finally, the balloon was microscopically inspected and leak tested, and it was found tubing damage from tool instrument; it passed leak testing.The balloon was functionally tested and it did not pass it, as it had an output pressure reading above specification.Additionally, the reported patient symptom is a known risk associated with implant of these devices 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 the patient with this artificial urinary sphincter (aus) presented recurring incontinence.It was reported a sizing problem with the cuff.The aus was explanted and replaced.There is no additional information 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: 23897057
• Report Number: 2124215-2025-93143
• Device Sequence Number: 4552521
• Product Code: EZY
• UDI-Device Identifier: 00878953000718
• UDI-Public: (01)00878953000718(17)280327(10)1100281367
• Combination Product (Y/N): N
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 01/22/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72400160
• Device Catalogue Number: 72400160
• Device Lot Number: 1100281367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: UPN 72400024 / LOT 1100149216; BALLOON: UPN 72400024 / LOT 1100149216; PUMP: UPN 72400098 / LOT 1100360129; PUMP: UPN 72400098 / LOT 1100360129
• Patient Sex: Unknown