MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number	18-3356
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	06/18/2019
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.During pre-procedure echocardiogram, a small effusion was noted at the left ventricular apex.The transeptal puncture was attempted 3 times, fully crossing the septum on the third attempt.During ablation of the right inferior pulmonary vein (ripv) the physician attempted to rotate the balloon catheter.During the attempt, the deflectable sheath introducer and balloon catheter coiled in the left atrium.The balloon was deflated and the sheath uncoiled by the physician which resulted in the catheter and sheath whipping to the superior aspect of the left atrium.The atraumatic tip of the catheter was outside of the sheath as described in the product labeling.On echocardiogram a worsening pericardial effusion was noted over the right side of the heart.Approximately 70cc of bright red blood was recovered before drainage slowed.This mdr 1225698-2019-00021 covers the sheath used in the procedure.A second mdr 1225698-2019-00020 will be submitted for the catheter used in the procedure.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure the patient developed a pericardial effusion requiring a pericardial window for drainage.It could not be confirmed how the effusion formed.A pericardial window was performed and a drain was placed.It was reported the patient was "doing fine" the following day.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 8791597
• Report Number: 1225698-2019-00021
• Device Sequence Number: 16628649
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152310
• 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): 07/15/2019

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: 08/31/2020
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: Q1370896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/15/2019
• 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: Other
• Patient Age: 57 YR