MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ DIAGNOSTIC CATHETER MEDIGUIDE ENABLED¿, MEDIUM SWEEP ELECTRODE SPACING; CATHETER, ELECTRODE RECORDING

Model Number	D402058
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During an endocardial ventricular tachycardia procedure, a pericardial effusion occurred.While mapping in the left ventricle the catheter was unable to be visualized and the signal of electrode 3 was lost.Electrode 3 was hidden from the mapping screen in order to continue the case.While mapping, the catheter was observed outside of the left ventricle and into the pericardium on the lateral wall.The procedure was stopped and an ultrasound revealed a pericardial effusion.The patient became hypotensive and a pericardiocentesis was performed which stabilized the patient.
Additional Manufacturer Narrative
Electrode 3 read as an open circuit.Electrode ring 3 was dissected to reveal that conductor wire 3 was fractured proximal to the weld joint, consistent with the open circuit detected and the reported signal issue.The cause of the fractured conductor wire is consistent with damage to the device during use.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.The cause of the pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is an inherent risk of any electrode placement.

• Brand Name: LIVEWIRE¿ DIAGNOSTIC CATHETER MEDIGUIDE ENABLED¿, MEDIUM SWEEP ELECTRODE SPACING
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 7761384
• Report Number: 2182269-2018-00101
• Device Sequence Number: 11077324
• Product Code: DRF
• UDI-Device Identifier: 05414734216890
• UDI-Public: 05414734216890
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101955
• 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,Followup
• Report Date (Section B): 08/28/2018

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: 06/30/2019
• Device Model Number: D402058
• Device Lot Number: 6260333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 08/28/2018
• 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