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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOBALLOON ABLATION

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CRYOBALLOON ABLATION   Back to Search Results
Event Date 03/27/2012
Event Type  Death   Patient Outcome  Death
Event Description

A (b)(6) female with history of atrial fibrillation underwent an (b)(6) study with cryoballoon ablation on (b)(6) 2012. She presented to the emergency department on (b)(6) 2012, with hematemesis and intercranial hemorrhage. She was emergently intubated and underwent an upper endoscopy which noted an esophageal perforation/erosion and possible atrial fistula. She subsequently died of the complications of the cryoablation.

 
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Type of DeviceCRYOBALLOON ABLATION
Device Event Key2545333
MDR Report Key2517658
Event Key2414411
Report NumberMW5024871
Device Sequence Number1
Product CodeGEH
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 03/30/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

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