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

Model Number	720133-01
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with an artificial urinary sphincter (aus) experienced problems as the device was not working correctly.A surgical procedure was performed where it was found that there was a crack in the cuff tubing; therefore, the cuff was removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The cuff was microscopically inspected and was identified to have folds.Cuff passed leakage test.Based on the information available and analysis results, the cause that led to the reported clinical observations of mechanical problem and hole/perforated could not be confirmed.D4 unique identifier (udi) for pump: (b)(6).D4 unique identifier (udi) for balloon: (b)(6).
Event or Problem Description
It was reported that this patient with an artificial urinary sphincter (aus) experienced problems as the device was not working correctly.A surgical procedure was performed where it was found that there was a crack in the cuff tubing; therefore, the cuff was 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: 21323934
• Report Number: 2124215-2025-06279
• Device Sequence Number: 8457146
• Product Code: EZY
• UDI-Device Identifier: 00878953005461
• UDI-Public: (01)00878953005461(17)240817(10)1100176075
• 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: 2023
• 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): 05/07/2025

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: 08/17/2024
• Device Model Number: 720133-01
• Device Catalogue Number: 720133-01
• Device Lot Number: 1100176075
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: 72400024LOT: 1100281801; BALLOON:UPN: 72400024LOT: 1100281801; PUMP:UPN: 72400098LOT: 1100285705; PUMP:UPN: 72400098LOT: 1100285705
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male