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 02/05/2019

Event Type  Injury  

Manufacturer Narrative

No device deficiency was reported.Pericardial effusion and cardiac tamponade are known potential adverse events documented in product labeling.The physician considers the cardiac tamponade likely occurred when the catheter was unintentionally pressed against the cardiac muscle while advancing toward the lspv, instead of when the left atrial appendage was inadvertently entered.There were also other catheters indwelling when the pericardial effusion was confirmed, however, those devices had not been recently manipulated.This mdr 1225698-2019-00021 is being filed because the complaint form listed both the heartlight catheter and deflectable sheaths as devices involved in the procedure.The catheter was reported on july 3, 2019 as mdr 1225698-2019-00017 but the sheath was not reported at that time.

Event Description

At the beginning of a pulmonary vein isolation (pvi) procedure, the catheter was inadvertently advanced into the left atrial appendage twice.The catheter was moved toward the left superior pulmonary vein (lspv).After 5 minutes the patient's blood pressure decreased and pericardial effusion was diagnosed by intracardiac echocardiography (ice).The pericardial effusion was drained through pericardiocentesis and blood transfusion was performed.After confirming the patient's blood pressure was stable and there was no increase in the pericardial effusion, the procedure was stopped with no ablation performed.

• 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: 8796047
• MDR Text Key: 151224854
• Report Number: 1225698-2019-00022
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• 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: 02/06/2019
• 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