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

Model Number	72400162
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	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the clinic because this artificial urinary sphincter (aus) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cuff connecting tube was identified.The cause of crack in the cuff connecting tube was not detailed by the hospital.All the components were removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected, and leak tested.Visual inspection revealed that the cuff presented a hole in the corner of a fold.The leak test revealed that the cuff had a fluid leak due to a tear fromthe wear present at the corner of a fold.The balloon was visually inspected, leak and functionally tested.The balloon passed the visual inspection, the leak test, and the functional test.The pump was visually inspected, leak tested, and functionally tested.The pump passed the visual inspection and leak testing and no visual damage or abnormalities were found.The pump did not pass the low flow test with an output reading below pressure, which is out of specification.The pump did not pass the resistor flow rate test with an output volume reading above the specification.Based on the information available and analysis results, the reason for mechanical issue and hole/perforate was most likely determined to be the cuff had fluid loss due to a tear from wear at a corner of a fold from the functional test; therefore,the reported allegations were confirmed.Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).
Event or Problem Description
It was reported that the patient went to the clinic because this artificial urinary sphincter (aus) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cuff connecting tube was identified.The cause of crack in the cuff connecting tube was not detailed by the hospital.All the components were removed and replaced.There were no patient complications 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: 21468476
• Report Number: 2124215-2025-11625
• Device Sequence Number: 16996773
• Product Code: EZY
• UDI-Device Identifier: 00878953000732
• UDI-Public: (01)00878953000732(17)230814(10)1000147902
• 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: 2019
• 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): 05/06/2025

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 Expiration Date: 08/14/2023
• Device Model Number: 72400162
• Device Catalogue Number: 72400162
• Device Lot Number: 1000147902
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2018
• 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: 1000244878.; BALLOON: UPN: 72400024 / LOT: 1000244878.; PUMP: UPN: 72400098 / LOT: 1000244660.; PUMP: UPN: 72400098 / LOT: 1000244660.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male