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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Perforation (2513)
Event Date 08/10/2020
Event Type  Injury  
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 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
Type of Device
HEARTLIGHT DEFLECTABLE SHEATH
Manufacturer (Section D)
CARDIOFOCUS
500 nickerson rd.
suite 500-200
marlboro MA 01752
Manufacturer Contact
ian christianson
500 nickerson rd.
suite 500-200
marlboro, MA 01752
5086587231
MDR Report Key10508555
MDR Text Key206151425
Report Number1225698-2020-00025
Device Sequence Number1
Product Code DRA
UDI-Device Identifier00868976000147
UDI-Public00868976000147
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2021
Device Model Number18-3356
Device Catalogue Number18-3356
Device Lot NumberQ1486376
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2019
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) Other; Required Intervention;
Patient Age72 YR
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