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

Model Number	72400166
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Incontinence (1928); Urinary Incontinence (4572)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).
Event or Problem Description
It was reported that an artificial urinary sphincter (aus) was implanted in (b)(6) 2023 and then, the patient presented a quick relapse of incontinence due to a mechanical failure.After a medical analysis, a surgical procedure was performed and during this, it was noticed that the aus cuff was perforated on one of the folds, which resulted in the removal and the replacement of the cuff.The patient and procedure outcome are unknown.
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).Upon receipt of the artificial urinary sphincter (aus) at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the returned cuff identified that it had a tear from tool/sharp instrument the median of the cuff shell.The cuff was tested.The testing conducted identified the cuff had fluid loss due to a tear from tool/sharp instrument damage along the median of the cuff shell.Visual inspection of the balloon confirmed that there were no damage or abnormalities.The balloon passed the leakage test; however, it did not pass the functional testing due to the output pressure.Based on analysis result, the allegation of incontinence, hole/perforated and mechanical issue was unable to be confirmed.Note that the sharp instrument damage found on the device is considered a secondary failure.Based on review of all information available and analysis results, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that an artificial urinary sphincter (aus) was implanted in (b)(6) 2023 and then, the patient presented a quick relapse of incontinence due to a mechanical failure.After a medical analysis, a surgical procedure was performed and during this, it was noticed that the aus cuff was perforated on one of the folds, which resulted in the removal and the replacement of the cuff.The patient and procedure outcome are unknown.

• 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: 21809122
• Report Number: 2124215-2025-21755
• Device Sequence Number: 15705674
• Product Code: EZY
• UDI-Device Identifier: 00878953000770
• UDI-Public: (01)00878953000770(17)270208(10)1100084313
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/10/2025

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: 72400166
• Device Catalogue Number: 72400166
• Device Lot Number: 1100084313
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: 1100246168; BALLOON: UPN: 72400024, LOT: 1100246168
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown