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

Model Number 401904

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer ref: 3005334138-2021-00461, 2182269-2021-00063.During a right-sided typical atrial flutter ablation procedure, the patient became hypotensive and a perforation occurred.The physician believed the perforation occurred in the wall of the right atrium while manipulating the catheters as a drop in blood pressure was seen.Difficulty placing both mapping catheters and the ablation catheter was noted.A pericardial effusion was then confirmed via a thoracic ultrasound probe when the ablation catheter was in the patient.A pericardiocentesis was performed in order to stabilize the patient and the procedure was then ended without performing any ablations.There were no performance issues with any of the abbott devices.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12238136
• MDR Text Key: 263812801
• Report Number: 2182269-2021-00062
• Device Sequence Number: 1
• Product Code: DRA
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER; TACTICATH¿ ABLATION CATHETER, SENSOR ENABLED
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 60