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	02/05/2019
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 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 or Problem 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
• Common Device Name: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 8796047
• Report Number: 1225698-2019-00022
• Device Sequence Number: 2043392
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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