MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC SUPREME ELECTROPHYSIOLOGY CATHETER; DIAGNOSTIC EP CATHETERS

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

Patient Problems Hemothorax (1896); Cardiac Perforation (2513)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event was requested but not received.

Event Description

Related manufacturer reference: 2182269-2020-00050, 3008452825-2020-00255, 3008452825-2020-00256, 3008452825-2020-00257.During ventricular tachycardia mapping in the left ventricle, a pericardial effusion occurred.After approximately an hour of mapping, using transseptal approach, the patient became hypotensive.An ultrasound confirmed a pericardial effusion for which a pericardiocentesis was administered.An additional ultrasound confirmed a hemothorax on the left side of the thorax, which was treated with a thorax drain.The cause and location of the pericardial effusion remains unknown, however it was noted the transseptal puncture was difficult.The patient was stable with minimal use of catecholamines and transferred to the icu.There were no performance issues with any abbott device.

Manufacturer Narrative

Additional information: g4, g7, h2, h3, h6, h10;   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 cardiac effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: SUPREME ELECTROPHYSIOLOGY CATHETER
• Type of Device: DIAGNOSTIC EP CATHETERS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 10098854
• MDR Text Key: 195001124
• Report Number: 2182269-2020-00051
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K002976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

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: 05/08/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS¿ NXT STEERABLE INTRODUCER.; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER.; LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR.; TRANSSEPTAL NEEDLE, BRK SERIES.
• Patient Outcome(s): Other