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

Model Number	72400098
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The pump was microscopically inspected and leak testing.It was found that clear tubing had a hole and suture tubing had a cut from sharp instrument.The cylinder passed the leakage testing and finally the pump did not pass the functional test due to pump clear tubing fluid leak was trimmed off.Cuff was microscopically inspected and was identified to have folds.Ms pump passed the leakage test.The cuff did not pass the visual inspection due to the cuff tube had fluid loss.Lastly the balloon passed visual inspection, leakage and functional tests.Based on the information available and analysis results, pump that did not pass the functional test could have caused or contributed to the reported clinical observation of mechanical problem.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) returned without initial reporter and any performance allegation information.Upon analysis of the returned components, the pump clear tubing had a hole, a fluid leak was observed, and pump failed poppet pressure test.There was no additional information provided.

• 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 ; 5086521217
• MDR Report Key: 23862538
• Report Number: 2124215-2025-82498
• Device Sequence Number: 9299553
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)270223(10)1100093219
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 1100093219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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 1100091523; CUFF: UPN 72400160 / LOT 1000528332
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown