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

Model Number	72400098
Medical Device Problem Codes	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	01/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the artificial urinary sphincter (aus) was not working properly and during the inspection, it was noticed there was a crack in the pump connecting tube.A surgical procedure was performed to replace the system.There were no further patient complications.
Event or Problem Description
It was reported that the patient visited the hospital due to the artificial urinary sphincter (aus) was not working properly.After two weeks, a surgical procedure was performed and during inspection, it was noticed there was a crack in the pump connecting tube.All components were removed and replaced.There were no further patient complications.
Additional Manufacturer Narrative
Correction to field b3: date of event.Upon receipt of this artificial urinary sphincter (aus) at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the device identified the pump tubing had a leak and wear due to filament fatigue.The pump tubing had two tears and a cut due to tool/sharp instrument damage.The pump was functionally tested after the pump tubing was trimmed down.The testing conducted confirmed the pump passed leakage test and visual test.Even there were several failure modes of the device that could lead to the allegation, which include but are not limited to a device malfunction, the reported crack in the pump connecting tube was not confirmed.The aus balloon was also analyzed, and it was confirmed through visual inspection that it had two damages from sharp instrument, folds and the leakage test did not pass due to it had leaks due to a pin hole and a tear from tool/sharp instrument damage in the shell.Finally, the aus cuff was also under analysis, the visual inspection concluded the component presented folds.Based on review of all information available and analysis results, a conclusion code of cause not established was assigned to this investigation.Concomitant product udi for balloon is (b)(4).

• 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: 21652386
• Report Number: 2124215-2025-16804
• Device Sequence Number: 7489538
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)280716(10)1100329798
• 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: 2024
• 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): 05/19/2025

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: 1100329798
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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: BALLON: UPN: 72400024, LOT: 1100335967; BALLON: UPN: 72400024, LOT: 1100335967; CUFF: UPN: 720133-01, LOT: 1100513421; CUFF: UPN: 720133-01, LOT: 1100513421
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male