MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; ELECTRODE RECORDING CATHETER

Model Number	401940
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	05/07/2019
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 cardiac effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.Further information regarding the event were requested but not received.
Event or Problem Description
Related manufacturer reference: 3005334138-2019-00256.During a supraventricular tachycardia ablation procedure a cardiac tamponade occurred.During the procedure, following ablation of the posterolateral la, the patient became hypotensive and a pericardiocentesis was performed.Transoesophageal echo confirmed the effusion and surgical intervention was performed and included placing patches around the proximal coronary sinus os to stabilize the patient.The patient was stabilized.There were no performance issues with any abbott devices.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8635811
• Report Number: 2182269-2019-00057
• Device Sequence Number: 16667015
• Product Code: DRF
• UDI-Device Identifier: 05414734202688
• UDI-Public: 05414734202688
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102721
• 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): 05/23/2019

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: 12/31/2021
• Device Model Number: 401940
• Device Catalogue Number: 401940
• Device Lot Number: 6711473
• 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: 05/07/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Outcome Attributed to Adverse Event: Required Intervention