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

Model Number	401908
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pericardial effusion may have been procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During a ventricular tachycardia ablation procedure a pericardial effusion occurred.After mapping for approximately 1 hour in the left ventricle, the catheter was noted to move outside the geometry.The patient became agitated and an echocardiogram revealed a small pericardial effusion.A pericardiocentesis was performed but ultimately the patient was transferred to the operating room for surgical repair of the perforation within the lateral left ventricle.The patient remained in stable condition.There were no performance issues with any abbott device.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8266400
• Report Number: 2182269-2019-00006
• Device Sequence Number: 2288308
• Product Code: DRA
• UDI-Device Identifier: 05414734202558
• UDI-Public: 05414734202558
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K913940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: 11/30/2020
• Device Model Number: 401908
• Device Catalogue Number: 401908
• Device Lot Number: 6236375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention