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

Model Number	72400098
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4) and for balloon is (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) went to the hospital because the product did not work properly.Two weeks later, as a result of the inspection, it was confirmed that there was a crack in the pump connecting tube, so all components were removed and replaced.No patient complications reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) went to the hospital because the product did not work properly.Two weeks later, as a result of the inspection, it was confirmed that there was a crack in the pump connecting tube, so all components were removed and replaced.No patient complications 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 analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.

• 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: 22738382
• Report Number: 2124215-2025-54554
• Device Sequence Number: 9240254
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)281130(10)1100406758
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1100406758
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 02/24/2026
• Date Device Manufactured: 12/02/2023
• 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 1100522114; BALLOON: UPN 72400024/ LOT 1100522114; CUFF: UPN 720133-01/ LOT 1100246199; CUFF: UPN 720133-01/ LOT 1100246199
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male