MAUDE Adverse Event Report: TELEFLEX MEDICAL LANGSTON CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/17/2023

Event Type  Injury  

Event Description

Langston catheter (teleflex) proximal port clotted.This produced inaccurate pressure measurements and made it difficult to diagnose severe aortic stenosis.Also routine flushing of the catheter could have sent a clot into the central circulation and caused stroke.Since teleflex put langston catheters back on the market, this is the second one i have used.The first one also had inaccurate pressure measurements.That is, pressures measured in the aorta were different between the proximal and distal ports.Thus, 2 out of 2 langston catheters i have used since they were re-introduced have produced unreliable and faulty pressure measurements.Incorrect measurements can produce inaccurate assessments of aortic valve area which can lead to mis-classification of severity of aortic stenosis which can lead to failure to treat severe life-threatening aortic stenosis or inappropriate replacement of aortic valves that are not severely stenosed.

• Brand Name: LANGSTON CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 17603654
• MDR Text Key: 322018726
• Report Number: MW5144858
• 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: Physician
• Type of Report: Initial
• Report Date: 08/18/2023

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White