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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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CARDIOFOCUS HEARTLIGHT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Nerve Damage (1979)
Event Date 03/13/2018
Event Type  Injury  
Event Description
It was reported that the patient suffered a "right phrenic nerve disconnection".Caller stated that they connected a pentaray catheter and ablation catheter to the piu and mapped the left atrium with the pentaray catheter, ablation catheter was not inserted into the patient.A laser focus device was used on the right pulmonary veins.It was after the laser focus device was used that the "right phrenic nerve disconnection" was observed via fluoroscopy.The laser focus device was removed from the patient and the ablation catheter was inserted and the procedure was completed using rf ablation.Patient is stable at this time and the "right phrenic nerve disconnection" is not resolved.Caller was using carto 3 system 34018.Additional information was received on 04/01/2018: physician's opinion regarding the cause of the adverse event is that it was procedure-related and that it occurred while ablating with the cardiofocus heartlight laser balloon catheter.The suspected device is the cardiofocus heartlight laser balloon catheter.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
HEARTLIGHT
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section D)
CARDIOFOCUS
MDR Report Key17523505
MDR Text Key321142718
Report NumberMW5130453
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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