MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT SHEATH

Model Number	18-3356
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1225698-2021-00028
• Device Sequence Number: 4802610
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown