MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number 18-3356

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Patient Problem/Medical Problem (2688)

Event Date 06/18/2019

Event Type  Injury  

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 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
• Type of Device: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; suite 500-200; marlboro, MA 01752 ; 5086587231
• MDR Report Key: 8791597
• MDR Text Key: 151106402
• Report Number: 1225698-2019-00021
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR