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

Model Number	72400025
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with recurrent urinary incontinence.The cuff and balloon were replaced, and the physician found the device had a fluid leak.There was no additional patient complications reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with recurrent urinary incontinence.The cuff and balloon were replaced, and the physician found the device had a fluid leak.There was no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the artificial urinary sphincter (aus) at our quality assurance laboratory the returned components underwent a thorough analysis.The balloon was visually inspected, leak tested, and functionally tested.The balloon presented folds but passed the leak testing.The balloon did not pass the functional testing.The cuff was examined, and the shell was worn from wear at a fold and a hole was identified.The cuff did not pass the leak testing performed.Based on the information available, the reported allegations were confirmed.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• 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: 19984443
• Report Number: 2124215-2024-50520
• Device Sequence Number: 7123249
• Product Code: EZY
• UDI-Device Identifier: 00878953000633
• UDI-Public: 00878953000633
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/07/2024

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: 03/22/2021
• Device Model Number: 72400025
• Device Catalogue Number: 72400025
• Device Lot Number: 0124873006
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2016
• 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: CUFF: UPN: 72404138LOT/SERIAL NUMBER: (B)(6).; CUFF: UPN: 72404138LOT/SERIAL NUMBER: (B)(6).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown