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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 Air Embolism (1697)
Event Type  Injury  
Manufacturer Narrative
No device deficiency reported. Procedure date and device lot number requested but could not be obtained. Relationship between device and report of st segment elevation suspected to be the result of air embolism cannot be determined. Air embolism 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, transient st segment elevation was noted. The treating physician attributed the st segment elevation to air entry through the deflectable sheath. An unknown medication was administered, the st segment elevation resolved, and the pvi procedure was completed. The patient was discharged without any symptoms or sequelae.
 
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Brand NameHEARTLIGHT
Type of DeviceHEARTLIGHT 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 Key11026943
MDR Text Key222015044
Report Number1225698-2020-00034
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K152310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number18-3356
Device Catalogue Number18-3356
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2020 Patient Sequence Number: 1
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