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

Model Number 72400024

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504)

Patient Problem Urinary Incontinence (4572)

Event Date 01/04/2024

Event Type  Injury  

Event Description

It was reported that the patient with this artificial urinary sphincter experienced recurring incontinence as the device was not working properly due to a fluid loss from the balloon.A surgical procedure was performed, and it was noted that the connecting tube from the balloon to the pump had a hole.; therefore, the balloon was removed and replaced.There were no patient complications reported.

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 device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Type of Device: 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: 18544985
• MDR Text Key: 333267278
• Report Number: 2124215-2024-02374
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953000626
• UDI-Public: 00878953000626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 72400024
• Device Catalogue Number: 72400024
• Device Lot Number: 1100312390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CUFF: UPN: 72404131 / LOT:1100324643; PUMP: UPN: 72404127 / LOT: 1100324991
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR