MAUDE Adverse Event Report: ST. JUDE MEDICAL LIVEWIRE 5F ELECTROPHYSIOLOGY CATHETER, EXTRA LARGE CURL; CATHETER, ELECTRODE, RECORDING, OR PROBE, ELECTRODE RECORDING

Lot Number 2093885

Device Problems Retraction Problem (1536); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Extubate (2402)

Event Date 06/20/2019

Event Type  malfunction  

Event Description

During attempts to cannulate the coronary sinus, the catheter became lodged in the inferior portion of the atrial septum/fold and could not be advanced or retracted.A biosense-webster soundstar intracardiac ultrasound (ice) catheter was advanced from the left femoral vein to the right atrium to visualize the catheter and septum.During retraction the ias could be seen bowing into the ra but the catheter would not release.Multiple attempts to dislodge the catheter were unsuccessful.A 7 fr mpa 1 coronary guide catheter was advanced over the catheter to attempt to release it but it could not be advanced to the tip due to resistance.All attempts at dislodging the catheter were unsuccessful.Cardiac surgery was considered.Pt was taken back to the cath lab and the catheter removed under fluoroscopic and ice guidance with counter traction.There was no effusion seen on ice after removal.The sheaths were removed and the pt extubated successfully.Fda safety report id# (b)(4).

• Brand Name: LIVEWIRE 5F ELECTROPHYSIOLOGY CATHETER, EXTRA LARGE CURL
• Type of Device: CATHETER, ELECTRODE, RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 8748791
• MDR Text Key: 149800801
• Report Number: MW5087703
• Device Sequence Number: 1
• Product Code: DRF
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2093885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 MO
• Patient Weight: 91