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

Model Number	72400167
Medical Device Problem Codes	Mechanical Problem (1384); Decrease in Pressure (1490)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that this artificial urinary sphincter was removed due to a technical deficiency with reduction in balloon volume and loss of effectiveness indicating patient incontinence.A new artificial urinary sphincter was implanted.No further patient complications were reported.
Event or Problem Description
It was reported that this artificial urinary sphincter was removed due to a technical deficiency with reduction in balloon volume and loss of effectiveness indicating patient incontinence.A new artificial urinary sphincter was implanted.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of the artificial urinary sphincter (aus) at our quality assurance laboratory the returned components underwent a thorough analysis.Inspection of the cuff, pump, and balloon found no abnormalities and passed the leak testing performed.The balloon did not pass the functional testing performed.Based on the information available, the reported observations 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; marlbourough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18945781
• Report Number: 2124215-2024-16977
• Device Sequence Number: 20840850
• Product Code: EZY
• UDI-Device Identifier: 00878953000787
• UDI-Public: 00878953000787
• 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: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 07/07/2013
• Device Model Number: 72400167
• Device Catalogue Number: 72400167
• Device Lot Number: 554412003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2009
• 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 690083003; BALLOON UPN 72400024 LOT 690083003; PUMP UPN 72400098 LOT 631108019; PUMP UPN 72400098 LOT 631108019
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female