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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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ST. JUDE MEDICAL TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number A-TCSE-DF
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Septic Shock (2068); Perforation of Esophagus (2399); Pericarditis (4448)
Event Type  Injury  
Event Description
Some days following the procedure, the patient experienced an esophageal fistula.The procedure on (b)(6) 2021 was completed with no complications or anomalies.On (b)(6) 2021, the patient presented with symptoms and a esophageal fistula.Was diagnosed for which surgical intervention was needed to resolve.There were no performance issues with any abbott devices.The patient is currently in stable condition.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.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.
 
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Brand Name
TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key12148984
MDR Text Key260935265
Report Number2184149-2021-00203
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
PMA/PMN Number
P130026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberA-TCSE-DF
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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