MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON

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	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency was reported.Pericardial effusion and cardiac tamponade are known potential adverse events documented in product labeling.The treating physician reported the patient's septum was very thin, and the physician indicated the laa may have had similar tissue thickness.The patient died less than 24 hours after the successful surgical repair of the perforation.The death was caused by a cranial hemorrhage attributed to coagulopathy and not the ablation device.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation the catheter and sheath were noticed to be in the left atrial appendage (laa).Almost immediately after moving to the left superior pulmonary vein a pericardial effusion was observed on intracardiac echocardiogram.The effusion quickly developed into cardiac tamponade and the patient condition worsened.The patient was taken to the operating room for further evacuation of the tamponade.Perforation of the laa was confirmed and the laa was repaired intra-operatively.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 9269382
• Report Number: 1225698-2019-00033
• Device Sequence Number: 1873048
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/01/2019

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: 06/30/2020
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Device Lot Number: 11582-023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 49