MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 565352CB1

Patient Problem Failure of Implant (1924)

Event Date 09/19/2023

Event Type  Injury  

Event Description

During the following procedure, (introduction of catheter, aorta**abdominal aortogram with pigtail marker catheter open brachial artery exposure for delivery of endovascular prosthesis, unilateral (list separately in addition to code for primary procedure)**left brachial artery cutdown vascular embolization or occlusion, artrial, (eg, congenital or acquired malformations, av malformations, av fistulas, aneurysms, pseudoaneurysms)**left internal iliac artery coiling) a piece of the catheter broke off in the patient.Tip of catheter became disconnected at a junction and separated.Surgeon was able to recover with a snare.Both pieces of the catheter were retrieved, and site was closed.

• Brand Name: IMPRESS ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 17827836
• MDR Text Key: 324499754
• Report Number: MW5146217
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 565352CB1
• Device Lot Number: I2593047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White