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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 Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 02/17/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.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) to treat atrial fibrillation the left atrial appendage was perforated by the introducer sheath.The perforation was surgically repaired and the patient was reported as doing well.
 
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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
MDR Report Key9831935
Report Number1225698-2020-00008
Device Sequence Number11520457
Product Code DRA
UDI-Device Identifier00868976000147
UDI-Public00868976000147
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K152310
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/13/2020
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 Date08/25/2021
Device Model Number18-3356
Device Catalogue Number18-3356
Device Lot NumberQ1656405
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/17/2020
Initial Report FDA Received Date03/13/2020
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 Required Intervention;
Patient Age59 YR
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