GUARDIAN II INTRO TORQUE
Received Nov 3, 2025 · Event occurred Oct 3, 2025
Report 2134812-2025-00042 · MDR key 23449499
Device
Product problems
- Gas/Air Leak
- Gas/Air Leak
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT: DURING THE CATH INTERVENTION, A CODE BLUE WAS CALLED DUE TO MD REPORTING THAT "AIR SUCKED INTO THE GUIDE."
Additional Manufacturer Narrative
(B)(4) THE CUSTOMER COMPLAINT OF A LEAK ISSUE WAS NOT ABLE TO BE CONFIRMED THROUGH INVESTIGATION OF THE RETURNED REPRESENTATIVE SAMPLE. VISUAL ANALYSIS OF THE RETURNED REPRESENTATIVE SAMPLE REVEALED NO DEFECTS OR ANOMALIES WERE PRESENT ON THE DEVICE. THE REPRESENTATIVE SAMPLE PASSED FUNCTIONAL TESTING AND SHOWED NO SIGNS OF LEAKAGE. A DEVICE HISTORY REVIEW WAS PERFORMED ON REPRESENTATIVE SAMPLE LOT#73C2501117, AND NO RELEVANT FINDINGS WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED AGAIN BUT NO RESPONSE WAS RECEIVED. BASED ON THE CUSTOMER REPORT AND SAMPLE RECEIVED, IT IS UNKNOWN IF THE GUARDIAN DEVICE WAS RESPONSIBLE FOR THIS REPORTED HARM AND NO PROBLEM WAS FOUND WITH THE RETURNED REPRESENTATIVE DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.