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

Model Number 72404131

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Event date: the exact of date when hematoma occurred is not available.Event date in this report is an estimate from date of awareness by boston scientific.There was no report of a device performance allegation.The reported patient symptom is a known risk associated with this implants and indicated as such in the device instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.

Event Description

It was reported that the patient had his artificial urinary sphincter (aus) removed in (b)(6) 2022 due to the patient developing a hematoma.The physician believed that the hematoma was the result of injury during the implant surgery.There were no device performance issues with the explanted aus.The patient underwent a re-implant surgery and a new aus was implanted.There were no further patient complications.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15459769
• MDR Text Key: 300294136
• Report Number: 2124215-2022-36265
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953003092
• UDI-Public: 00878953003092
• Combination Product (y/n): Y
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2023
• Device Model Number: 72404131
• Device Catalogue Number: 72404131
• Device Lot Number: 1100020989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male