MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN; IRRIGATED ABLATION CATHETER

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

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Type  Death  

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 incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2030404-2019-00078.The following was published in the lebanese medical journal in an article titled ¿high incidence of steam pop formation with therapy cool flex rf ablation catheter by el baba m, al jaroudi w, nader m, et al., 2019 (volume 67).¿open irrigation catheters have the advantage of delivering greater power without increasing the temperature of the catheter tip, which enables deeper and wider lesions without the formation of coagulum on catheters.A total of 54 consecutive patients underwent rf ablation: 12 patients with the therapy¿ cool flex¿ catheter (group 1) and 42 patients with a non-abbott catheter (group 2).Patients in group 1 were significantly older, had more coronary artery disease and heart failure and more likely to be on anticoagulation than those in group 2.There was a significantly greater incidence of steam pop in the therapy¿cool flex¿ group (33.3% vs.2.4%, p < 0.05) and more pericardial effusion (16.6% vs.0%, p < 0.05).One of the two patients that had a pericardial effusion went into tamponade and subsequently passed away on the table.This patient had severe ischemic cardiomyopathy with an ejection fraction at 10% and was undergoing a ventricular tachycardia (vt) ablation for vt storm.¿.

• Brand Name: THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN
• Type of Device: IRRIGATED ABLATION CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8934466
• MDR Text Key: 155634013
• Report Number: 2030404-2019-00077
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death