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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

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MEDTRONIC CRYOCATH LP ARCTIC FRONT CARDIAC CRYOABLATION CATHETER Back to Search Results
Model Number 2AF232
Event Date 09/18/2011
Event Type  Death  
Event Description

A cryoablation procedure was performed on (b)(6) 2011. Pulmonary veins were 14-19mm, physician used 23mm balloon catheter. Procedure involved a single transeptal puncture as the physician used the achieve mapping catheter. Left superior pulmonary vein ablated using cryoballoon with 4 freezes of 4 minutes in duration with a lowest temperature of -75 degrees c. Left inferior pulmonary vein treated with 5 freezes of 4 minutes with the cryoballoon with a lowest temperature of -69 degrees c. During treatment of the right sided pulmonary veins with the cryoballoon, the physician observed that the diaphragm was sluggish and the temperatures were at -74 degrees c. Ablation was stopped and veins were found to be isolated so the physician stopped the procedure and all was fine. Physician finished with a flutter line using rf. The patient seemed well and went home the next day. At his one month check, the patient reported a cough. Chest x-ray obtained with no issues noted and patient checked out fine and went home. Two weeks later (approximately 6 weeks post procedure), the patient was admitted to hospital with symptoms of tia/stroke and 2 weeks of fever and weight loss. Patient began to have seizures. Ct/tee showed vegetation near the antrum to the lspv and patient was taken to the o. R. For surgical removal. During procedure, surgeon noted what he thought was a communication from the la but did not uncover the source. Vegetation was removed and the esophagus was noted as being directly behind this site. Patient never woke from the effects of the stroke, the family disconnected care and he passed away. The pathologist report was finalized and medtronic was notified of the pathology report contents on january 13, 2012. Although the pathologist didn't find any gross evidence of ae fistula, the brain pathology showed vegetative fibers, thus inferring indirect evidence of esophageal fistula.

 
Manufacturer Narrative

The device was not returned for investigation. Bin files were analyzed and did not show any system notices or errors during the injections performed on 2011-(b)(6). There was no indication of product malfunction. The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted.

 
Event Description

A cryoablation procedure was performed on 2011-(b)(6). Approximately 1 month post procedure, the patient returned to the hospital with fever and (b)(6) weight loss in two weeks. Patient underwent tee and mri which showed concern in (b)(6). The patient underwent surgery on 2011-(b)(6) for removal of abscess. The patient was transferred to a hospice and died at the beginning of (b)(6) 2011 (the exact date of death is not known). No additional details were provided and autopsy results were not yet available as per the physician.

 
Manufacturer Narrative

 
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Brand NameARCTIC FRONT CARDIAC CRYOABLATION CATHETER
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 Key2319976
MDR Report Key2300193
Event Key2197089
Report Number3002648230-2011-00191
Device Sequence Number1
Product CodeOAE
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date03/01/2012
Device MODEL Number2AF232
Device Catalogue Number2AF232
Device LOT Number94266
OTHER Device ID NumberNOT APPLICABLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/13/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/01/2011
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: 10/18/2011 Patient Sequence Number: 1
Treatment
ACHIEVE MAPPING CATHETER
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