MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT SHEATH

Model Number 18-3356

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

Patient Problem Arrhythmia (1721)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

No device deficiency was reported which may have contributed to the report of st segment elevation.The physician did not specifically identify a device cause for the st elevation, only that device involvement was possible.St elevation is a known possible complication of catheter ablation procedures.Both a catheter and sheath are used to perform the pvi procedure, with only the catheter returned.No deficiency which may have led to the reported event was found in the returned device.

Event Description

During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, st elevation was noted before ablation began.Coronary angiography showed slight stenosis so nitroglycerin was administered, slightly improving the st elevation.The pvi procedure was performed.No air entry or thrombus were identified and the possibility of coronary spasms was not denied.The cause of the st elevation is not known.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT 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: 12914203
• MDR Text Key: 281583847
• Report Number: 1225698-2021-00028
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: E2063177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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