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

Model Number	720133-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not working properly.A surgical procedure was performed, during which inflation issues in the pump and fluid loss in the cuff were noted; therefore, all components were removed and replaced.There were no patient compilations.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not working properly.A surgical procedure was performed, during which inflation issues in the pump and fluid loss in the cuff were noted; therefore, all components were removed and replaced.There were no patient compilations.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected, during which tool marks and two tears along the lateral edge of the cuff shell were identified, consistent with sharp instrument damage.Due to that finding, the component was not leakage tested.The balloon was visually inspected, leak and functionally tested.No damage or abnormalities were noted under visual evaluation, and no leaks were identified; however, the balloon did not pass functional examination due to an output pressure above specification.The pump was visually inspected, leak and functionally tested, and it passed all testing.Based on the information available and analysis results, the balloon not passing functional evaluation could have caused or contributed to the reported clinical observation of device not working properly.

• 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: 21037212
• Report Number: 2124215-2024-82018
• Device Sequence Number: 20740961
• Product Code: EZY
• UDI-Device Identifier: 00878953005461
• UDI-Public: 00878953005461
• 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: 2024
• 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): 02/25/2025

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: 02/05/2025
• Device Model Number: 720133-01
• Device Catalogue Number: 720133-01
• Device Lot Number: 1100255500
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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: 72400023 / LOT: 1100040917; BALLOON: UPN: 72400023 / LOT: 1100040917; PUMP: UPN: 72400098 / LOT: 1100330678; PUMP: UPN: 72400098 / LOT: 1100330678
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown