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

Model Number 401904

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 12/10/2021

Event Type  Injury  

Event Description

During a supraventricular tachycardia ablation procedure, the catheter became bent and a snare was needed to remove the device.The catheter was placed into the right atrium, the actuator handle was turned to place into the device into the coronary sinus (cs).The physician stated the patients atrium was normal size and he was having difficulties cannulating the cs.An attempt to straighten the curve of the catheter was unsuccessful.The device was able to be rotated 360 degrees without resistance.The catheter could not be advanced into the svc, ivc, or rv, when attempting to straighten and remove the catheter.After attempting to remove the catheter for approximately 30 minutes, a snare was placed into the right atrium and attached to the distal portion of the catheter.While holding the distal portion stable, the catheter was able to be removed.The catheter was replaced with a device from the same model with no consequences to the patient.

Manufacturer Narrative

One 7f, duo-decapolar, super large curl, livewire ep catheter was received for evaluation.Visual inspection revealed bends in the shaft 5.0¿ and 7.0¿ proximal to the distal tip.The catheter shaft was able to deflect when actuating the steering mechanism; although it no longer met specifications for curve shape due to bends in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the bends and reported removal difficulty 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13011834
• MDR Text Key: 282287028
• Report Number: 2182269-2021-00092
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202534
• UDI-Public: 05414734202534
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401904
• Device Catalogue Number: 401904
• Device Lot Number: 7963883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention