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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

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MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number 2AF284
Event Date 01/30/2013
Event Type  Death  
Manufacturer Narrative

The device was not returned for investigation. Bin files were analyzed and do not show any system notice or issues for the date of the procedure. Bin files show that at least 20 injections were performed with the catheter with lowest temperature of -61 degrees c at the 6th injection. There was no indication of product malfunction. This report will be recorded and trended.

 
Event Description

A cryoablation procedure was performed on (b)(6) 2013. The patient complained of flu-like symptoms and was admitted to the hospital on (b)(6) 2013. Many tests were performed including a ct and mri. The patient lost consciousness while showering at the hospital. After further tests, the physicians found a vegetation / thrombus in the left inferior pulmonary vein. The thrombus then traveled to the left anterior descending coronary artery and the patient died. An autopsy was performed (b)(6) 2013 and confirmed that the patient had an esophageal fistula. There was a dime-size hole in the esophagus.

 
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Brand NameARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
Type of DevicePERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section F)
MEDTRONIC CRYOCATH LP
16771 chemin ste-marie
kirkland,qc
CANADA H9H 5H3
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
16771 chemin ste-marie
kirkland,qc
CANADA H9H 5H3
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
16771 chemin ste-marie
kirkland,qc
CANADA H9H 5H3
Manufacturer Contact
voula radiotis
16771 chemin ste-marie
kirkland,qc  
CANADA   H9H 5H3
(514) 694 -1212
Device Event Key3029246
MDR Report Key3003846
Event Key2900380
Report Number3002648230-2013-00037
Device Sequence Number1
Product CodeOAE
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/24/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date12/01/2013
Device MODEL Number2AF284
Device Catalogue Number2AF284
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/24/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/21/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/14/2013 Patient Sequence Number: 1
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