MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE; CATHETER, STEERABLE

Model Number 401904

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

During the procedure, when attempting to position the catheter into the coronary sinus it became entangled on itself and a snare was used for removal.Electrodes 5-6 appeared to be caught on electrodes 19-20.Several different ways to were tried to release the device with no success.Several catheters were attempted to pass through the center of the loop on the livewire unsuccessfully.After approximately an hour, a snare catheter was used with force and the catheter was untangled and removed from the patient.The patient had too much x-ray and had been under anesthesia for too long and the case was cancelled.Visible kinks were noted where the catheter was caught on itself.The patient was not harmed but did receive several x-rays and was under general anesthesia for a few hours.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One 7f, duo-decapolar, super large curl, livewire ep catheter was received for evaluation.One video was also submitted for evaluation.The video appears to show the catheter under fluoroscopy during the procedure.Two kinks were confirmed on the catheter shaft and the catheter no longer met specifications for curve shape due to the kinks in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kinks in the shaft are consistent with damage during use.The cause of the reported entanglement remains unknown.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 11440358
• MDR Text Key: 239068029
• Report Number: 2182269-2021-00025
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202534
• UDI-Public: 05414734202534
• Combination Product (y/n): N
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 401904
• Device Catalogue Number: 401904
• Device Lot Number: 7730612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention