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

Model Number 72400025

Device Problems Fluid/Blood Leak (1250); 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 (aus) experienced urinary incontinence.A revision surgery was performed, upon examination fluid leakage due to a hole in the balloon was found.The balloon was explanted and replaced.No additional patient complications were 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 devices 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: 18553827
• MDR Text Key: 333380003
• Report Number: 2124215-2024-02961
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953000633
• UDI-Public: 00878953000633
• 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: 01/22/2024

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 Expiration Date: 01/27/2010
• Device Model Number: 72400025
• Device Catalogue Number: 72400025
• Device Lot Number: 410446017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72400160 / LOT: 420554008; PUMP: UPN: 72400098 / LOT: 419832002
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR