MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number 18-3356

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Perforation (2513)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

No device deficiency reported.Cardiac perforation is a known potential adverse event for catheter ablation procedures disclosed in product labeling.

Event Description

During a pulmonary vein isolation (pvi) to treat atrial fibrillation the left atrial appendage was perforated by the introducer sheath.The perforation was surgically repaired and the patient was reported as doing well.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro, ma
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; suite 500-200; marlboro, ma ; 6587231
• MDR Report Key: 9831935
• MDR Text Key: 189494715
• Report Number: 1225698-2020-00008
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K152310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: Q1656405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• 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): Required Intervention
• Patient Age: 59 YR