MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER

Model Number	18-4000-27A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Patient Problem/Medical Problem (2688)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
While performing an initial pvi, the patient was noted to have increasing pericardial effusion using intracardiac echocardiogram (ice).The procedure was stopped after ablating the lspv and approximately 75% of the lipv.During initial attempt to access the left superior pulmonary vein (lspv) the catheter appeared to be in the left atrial appendage (laa) instead of the lspv.The catheter balloon was inflated and the catheter was confirmed to be in the laa.The catheter balloon was deflated, the catheter was repositioned, and the lspv was ablated.The catheter was moved to the left inferior pulmonary vein (lipv) when it was noted the effusion continued to increase.The physician stopped the ablation procedure and pericardiocentesis was successfully performed.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 8671945
• Report Number: 1225698-2019-00014
• Device Sequence Number: 16203983
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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 Date: 10/31/2019
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Device Lot Number: 10779-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE PRECISION SYSTEM; HD GRID DIAGNOSTIC CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR