MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

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

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

Related manufacturing ref: the following article was published in the heart rhythm society vol 16, no6, june 2019 titled ¿hybrid thoracoscopic epicardial ablation of right ventricular outflow tract in patients with brugada syndrome.A cardiac tamponade occurred 22 days after the procedure that required emergency drainage from subxiphoid access and 7 days of hospitalization in the intensive care unit.Mtd.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported cardiac tamponade remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

Event Description

Related manufacturing ref: 3005334138-2019-00357.

• Brand Name: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8772249
• MDR Text Key: 150426293
• Report Number: 3005334138-2019-00358
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 06/12/2019; 07/19/2019
• Supplement Dates FDA Received: 07/09/2019; 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other