FDA Adverse Event Injury Summary report: N

THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB

MDR report key: 2121015 · Received June 9, 2011

Report

Report Number: 2030404-2011-00169
Event Type: Injury
Date Received: June 9, 2011
Date of Event: May 16, 2011
Report Date: May 16, 2011
Manufacturer: ST. JUDE MEDICAL, IRVINE
Product Code: OAD
PMA / PMN Number: P060019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

WE WERE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IT NOTED WITHIN THE IFU.

Description of Event or Problem · 1

IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERFORATION AND A TAMPONADE OCCURRED. IT APPEARED THAT THE ABLATION CATHETER PUSHED THROUGH THE PERICARDIUM TOWARDS THE VENTRICLE AS VENTRICULAR SIGNALS WERE NOTED ON THE ABLATION CATHETER. THE TAMPONADE WAS RECOGNIZED LATER DUE TO A DECREASE IN BLOOD PRESSURE. THE LEFT PULMONARY VEINS WERE ABLATED (MAX 30W WITH 15 ML FLOW). AFTER IT WAS RECOGNIZED, THE PROCEDURE WAS ABORTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE CATHETER DID NOT SHOW ANY ABNORMALITIES DURING OR AFTER THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB	CARDIAC ABLATION PERCUTANEOUS CATHETER	OAD	ST. JUDE MEDICAL, IRVINE	88015	3303885

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	OPTIMA CATHETER: NO LOT NUMBER AVAILABLE\| CS CATHETER (BARD)