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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
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ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX Back to Search Results
Model Number EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Cardiac Tamponade (2226)
Event Type  Injury  
Manufacturer Narrative
Case-(b)(4) there was no device malfunction reported, information obtained for event was through a presentation.
 
Event Description
Information received during a poster presentation at (b)(6) ¿ from a study convergent ablation for persistent atrial fibrillation single center experience conducted (b)(6) 2013-(b)(6) 2016.Two serious complications were noted, significant hemopericardium with tamponade and acute stroke.The time frame of adverse events and the device attribution of adverse events could not be confirmed.
 
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Brand Name
EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
Type of Device
EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
Manufacturer (Section D)
ATRICURE, INC.
7555 innovation way
mason OH 45040
Manufacturer (Section G)
ATRICURE, INC.
7555 innovation way
mason OH 45040
Manufacturer Contact
anupam bedi
MDR Report Key6694395
MDR Text Key79357677
Report Number3011706110-2017-00060
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Initial
Report Date 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberEPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS
Device Catalogue NumberCDK-1413
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Disability;
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