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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH
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CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH Back to Search Results
Model Number 18-3356
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 08/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No device deficiency noted.The cause of the tamponade could not be conclusively determined but may have involved the manufacturer's device.Cardiac perforation is a known potential 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 prior to ablation.Pericardiocentesis was performed followed by successful cardiac surgery.
 
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Brand Name
HEARTLIGHT
Common Device Name
HEARTLIGHT DEFLECTABLE SHEATH
Manufacturer (Section D)
CARDIOFOCUS
500 nickerson rd.
suite 500-200
marlboro MA 01752
MDR Report Key10508555
Report Number1225698-2020-00025
Device Sequence Number11639819
Product Code DRA
UDI-Device Identifier00868976000147
UDI-Public00868976000147
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K152310
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/09/2020
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 Date03/31/2021
Device Model Number18-3356
Device Catalogue Number18-3356
Device Lot NumberQ1486376
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/10/2020
Initial Report FDA Received Date09/09/2020
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 Other; Required Intervention;
Patient Age72 YR
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