MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC LANGSTON DUAL LUMEN CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 5540

Device Problems Filling Problem (1233); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2022

Event Type  malfunction  

Event Description

The physician withdrew from the side port of the langston after the lv gram(ventriculography) was completed and air was withdrawn from the side port.No air was injected into the left ventricle.The physician also reported that it took 5-6 seconds for the ventricle to be filled on the lv gram from the power injector instead of the normal 2-3 seconds.Fda safety report id# (b)(4).

• Brand Name: LANGSTON DUAL LUMEN CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC
• MDR Report Key: 15754115
• MDR Text Key: 303335381
• Report Number: MW5113127
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5540
• Device Lot Number: 720148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White