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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 Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Perforation (2513)
Event Date 09/13/2021
Event Type  Injury  
Manufacturer Narrative
No device deficiency was reported. Cardiac tamponade is a known potential adverse event of catheter ablation procedures disclosed in product labeling. The blood pressure drop was noted coincident with the positioning of another manufacturer's mapping catheter and sheath in the right superior pulmonary vein. The deflectable sheath was then moved to the left inferior pulmonary vein and further blood pressure decrease was noted. The physician did not conclusively exclude the deflectable sheath as a possible contributing cause of the cardiac tamponade. It was also reported the ablation catheter tip was completely withdrawn into the deflectable sheath. This is contrary to product labeling in which the soft distal tip of the catheter is recommended to be extended from the sheath during sheath movemement. It cannot be determined if this deviation from the instructions from use contributed to this adverse event.
 
Event Description
During a pulmonary vein isolation procedure to treat atrial fibrillation, a drop in blood pressure occurred and cardiac tamponade was diagnosed with echocardiography. The cardiac tamponade was successfully treated by pericardiocentesis. The physician believes the cause of the cardiac tamponade was an electrophysiology catheter and sheath, made by a different manufacturer, which were used to check for potentials in the right superior pulmonary vein. However, the physician could not exclude the deflectable sheath as a possible cause of the cardiac tamponade.
 
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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 Key12601476
MDR Text Key275901461
Report Number1225698-2021-00020
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number18-3356
Device Catalogue Number18-3356
Device Lot NumberE2063179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2021
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: 10/08/2021 Patient Sequence Number: 1
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