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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON
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CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON Back to Search Results
Model Number 18-4000-27A
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 11/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.The cause of the tamponade was not conclusively determined but likely involved the manufacturer's device.Cardiac perforation is a known adverse event for catheter ablation procedures disclosed in product labeling.
 
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, cardiac tamponade occurred while ablating the left superior pulmonary vein.After verification of the tamponade with ultrasound, pericardiocentesis was performed followed by cardiac surgery.
 
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Brand Name
HEARTLIGHT
Common Device Name
HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON
Manufacturer (Section D)
CARDIOFOCUS
500 nickerson rd.
suite 500-200
marlboro MA 01752
MDR Report Key10972727
Report Number1225698-2020-00033
Device Sequence Number16952457
Product Code OAE
UDI-Device Identifier00868976000178
UDI-Public00868976000178
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
P150026
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/30/2020
Device Model Number18-4000-27A
Device Catalogue Number18-4000-27A
Device Lot Number11959-007
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/10/2020
Initial Report FDA Received Date12/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other;
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