MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number	18-3356
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency was reported.Cardiac tamponade is a known potential adverse event of catheter ablation procedures disclosed in product labeling.The blood pressure drop was noted coincident with the positioning of another manufacturer's mapping catheter and sheath in the right superior pulmonary vein.The deflectable sheath was then moved to the left inferior pulmonary vein and further blood pressure decrease was noted.The physician did not conclusively exclude the deflectable sheath as a possible contributing cause of the cardiac tamponade.It was also reported the ablation catheter tip was completely withdrawn into the deflectable sheath.This is contrary to product labeling in which the soft distal tip of the catheter is recommended to be extended from the sheath during sheath movemement.It cannot be determined if this deviation from the instructions from use contributed to this adverse event.
Event or Problem Description
During a pulmonary vein isolation procedure to treat atrial fibrillation, a drop in blood pressure occurred and cardiac tamponade was diagnosed with echocardiography.The cardiac tamponade was successfully treated by pericardiocentesis.The physician believes the cause of the cardiac tamponade was an electrophysiology catheter and sheath, made by a different manufacturer, which were used to check for potentials in the right superior pulmonary vein.However, the physician could not exclude the deflectable sheath as a possible cause of the cardiac tamponade.

• 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: 12601476
• Report Number: 1225698-2021-00020
• Device Sequence Number: 3373551
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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: 03/28/2023
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: E2063179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/08/2021
• 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: 55 YR