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

Model Number	401904
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2182269-2021-00092
• Device Sequence Number: 14712499
• Product Code: DRA
• UDI-Device Identifier: 05414734202534
• UDI-Public: 05414734202534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown