MAUDE Adverse Event Report: ANGIODYNAMICS, INC. MARINER OMNI FLUSH ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 11732205

Patient Problem Foreign Body In Patient (2687)

Event Date 04/08/2024

Event Type  Other  

Event Description

During pmeg (physician-modified endovascular graft) procedure a mariner omni flush angiographic catheter was used and while in use, a part of the tip broke off at the wall of the patient's aorta.This piece was not able to be retrieved.

• Brand Name: MARINER OMNI FLUSH ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 19152898
• MDR Text Key: 340874657
• Report Number: MW5154048
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11732205
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Patient Sequence Number: 1
• Treatment: D-EVOLUTFX-2329.
• Patient Age: 61 YR
• Patient Sex: Female