MAUDE Adverse Event Report: CORTEX INC ABLACATH CATHETER (OPTIMAP CATHETER); CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	AB-0003-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had atrial fibrillation ablation performed on (b)(6) 2023.The patient was seen in the clinic on (b)(6) 2023 due to mild chest pain and difficulty breathing for 2 days.An echocardiogram showed a large pericardial effusion w/tamponade and patient was admitted same day.Pericardiocentesis was performed the next day.610ml fluid was drained.A repeat echocardiogram on (b)(6) 2023 showed minimal pericardial effusion.The patient decreased colchicine, added prednisone, continued eliquis and propafenone.Increase metoprolol to bid for rate control.Patient was discharged on (b)(6) 2023.
Additional Manufacturer Narrative
The treating physician initially noted that the event was not related to the device.The event was later adjudicated by the cec ((b)(6) 2024) as possibly related to the device and standard of care procedure.

• Brand Name: ABLACATH CATHETER (OPTIMAP CATHETER)
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): CORTEX INC; 3550 scott blvd ste 37b; santa clara CA 95054
• Manufacturer (Section G): CORTEX INC.; 3550 scott blvd ste 37b; santa clara CA 95054
• Manufacturer Contact: laurie lewandowski ; 3550 scott blvd ste 37b; santa clara, CA 95054
• MDR Report Key: 20516255
• Report Number: 3013627970-2024-00001
• Device Sequence Number: 12711232
• Product Code: MTD
• UDI-Device Identifier: 00860457001544
• UDI-Public: 00860457001544
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: 06/28/2024
• Device Model Number: AB-0003-50
• Device Lot Number: Q8513870
• 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: 03/08/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 74 KG