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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
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Death (1802); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Vomiting (2144); Perforation of Esophagus (2399)
Event Date 03/27/2012
Event Type  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
MDR Report Key2517658
MDR Text Key21759123
Report NumberMW5024871
Device Sequence Number1
Product Code GEH
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 03/30/2012 Patient Sequence Number: 1
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