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

Model Number	720133-01
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the hospital two weeks before the operation because the artificial urinary sphincter (aus) did not work properly.As a result of the inspection, it was confirmed that there was a crack in the cuff connecting tube, due to this, all components were replaced.The surgery was completed with a different cuff 4.5cm.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The visual inspection confirmed the cuff presented folds and the cuff was functionally tested.The leaking testing conducted did not identify defect or malfunction.The crack on cuff connecting tube complaint was not confirmed, however, there are several failure modes of the device that could lead to the crack reported, which include but are not limited to a device malfunction.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 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 hospital two weeks before the operation because the artificial urinary sphincter (aus) did not work properly.As a result of the inspection, it was confirmed that there was a crack in the cuff connecting tube, due to this, all components were replaced.The surgery was completed with a different cuff 4.5cm.There were no patient complications.

• 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: 21318490
• Report Number: 2124215-2025-05933
• Device Sequence Number: 7918403
• Product Code: EZY
• UDI-Device Identifier: 00878953005461
• UDI-Public: (01)00878953005461(17)220203(10)1000391080
• 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: 2021
• 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): 04/23/2025

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: 02/03/2022
• Device Model Number: 720133-01
• Device Catalogue Number: 720133-01
• Device Lot Number: 1000391080
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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#: 1000398311; BALLOON: UPN 72400024, LOT#: 1000398311; PUMP: UPN: 72400098, LOT#: 100036229; PUMP: UPN: 72400098, LOT#: 100036229
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male