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 Stroke/CVA (1770); Fistula (1862); Nerve Damage (1979); Stenosis (2263); Cardiac Perforation (2513); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

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 incidents remain unknown.

Event Description

Related manufacturing ref: 3005334138-2019-00289, 2030404-2019-00039, 3005334138-2019-00288.The following was published in the journal of cardiology in an article titled "clinical characteristics and rhythm outcome of catheter ablation of hemodynamically corrected valvular atrial fibrillation" by jung ok kim.Although the hemodynamic burden and structural substrate contribute to valvular atrial fibrillation (vaf) mechanisms, the role of catheter ablation has rarely been reported.Clinical characteristics, mapping findings, and long-term rhythm outcomes were investigated after catheter ablation of hemodynamically corrected vaf.Complications noted during the study included cardiac perforations, atrio-esophageal fistulas, cva, av heart blocks, femoral artero-venous (av) fistulas, pulmonary vein stenosis, and phrenic nerve palsies.

• 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: 8666940
• MDR Text Key: 146947825
• Report Number: 2030404-2019-00038
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• 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: 05/15/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other