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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER
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CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER Back to Search Results
Model Number 18-2531-N250
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Nerve Damage (1979); Patient Problem/Medical Problem (2688)
Date of Event 10/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No device deficiency was reported.Phrenic nerve damage leading to diaphraghmatic paralyis is a known potential adverse event.
 
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure, loss of phrenic nerve capture was observed through compound muscle action potential (cmap) monitoring while treating the right superior pulmonary vein.Using fluoroscopy the patient's diaphragm was observed to have slightly risen but its movement had not completely stopped.The patient was asymptomatic throughout.
 
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Brand Name
HEARTLIGHT
Common Device Name
HEARTLIGHT CATHETER
Manufacturer (Section D)
CARDIOFOCUS
500 nickerson rd.
suite 500-200
marlboro MA 01752
MDR Report Key9347374
Report Number1225698-2019-00036
Device Sequence Number2269214
Product Code OAE
UDI-Device Identifier00868976000178
UDI-Public00868976000178
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P150026
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/20/2019
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 Date11/30/2019
Device Model Number18-2531-N250
Device Catalogue Number18-2531-N250
Device Lot Number10892-16
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2019
Initial Report FDA Received Date11/20/2019
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;
Patient Age70 YR
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