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

Model Number	72400098
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for balloon is (b)(4).
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) device experienced recurring incontinence.It was noted that the patient had the device for 8 years, and the physician found the urethra had slightly narrowed, which led to the decision to replace the device.During the procedure, the device was explanted without any complications.An endoscopic examination revealed there were no significant issues, so it was decided to proceed with implantation of a new aus device.After securing the abdominal space, significant bleeding occurred while attempting to secure the urethral space.The bleeding was controlled approximately two hours later.However, due to the patient's condition, the physician decided to not implant a new aus device.The patient is currently receiving medication based treatment to allow time for recovery.There were no further patient complications.This report is for the bleeding and aborted implant procedure.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) device experienced recurring incontinence.It was noted that the patient had the device for 8 years, and the physician found the urethra had slightly narrowed, which led to the decision to replace the device.During the procedure, the device was explanted without any complications.An endoscopic examination revealed there were no significant issues, so it was decided to proceed with implantation of a new aus device.After securing the abdominal space, significant bleeding occurred while attempting to secure the urethral space.The bleeding was controlled approximately two hours later.However, due to the patient's condition, the physician decided to not implant a new aus device.The patient is currently receiving medication based treatment to allow time for recovery.There were no further patient complications.This report is for the bleeding and aborted implant procedure.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for balloon is (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.The pump passed visual inspection, leakage testing, and functional testing with no damage or abnormalities observed.The balloon passed visual inspection and leak testing; however, it did not pass functional testing, showing an output pressure of 71.5 cmh2o, which is above the specification range (61-70 cmh2o).The balloon not passing functional testing could have caused or contributed to the device performance; however no product allegations were made.The reported patient symptom of hemorrhage is a known risk associated with this device type and is 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: 23468360
• Report Number: 2124215-2025-76686
• Device Sequence Number: 15655324
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)300519(10)1100732642
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/06/2026

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: 1100732642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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 1100717940, UPN 72400024; BALLOON LOT 1100717940, UPN 72400024
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male