MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF283

Device Problem Gas/Air Leak (2946)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Cyanosis (1798); Embolism (1829); Neurological Deficit/Dysfunction (1982); ST Segment Elevation (2059); Vascular System (Circulation), Impaired (2572); Exit Block (2628)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the sheath was difficult to introduce.A smaller caliber introducer was used to predilate.When advancing the balloon catheter the patient suffered a complete blockage and stimulation was used to recover the normal sinus rhythm.The patient showed high st elevation, cyanosis symptoms and didn't respond to any stimulus.The procedure was aborted and an air thromboembolism was confirmed over the full right coronary artery.Ecmo (extracorporeal membrane oxygenation) was initiated.During the patient stimulation the doctors became aware the patient suffered a mechanical block; it was noted the patient went into cardiac arrest, and cardiopulmonary resuscitation (cpr) was started.The patient then went into ventricular fibrillation (vf) and two external defibrillator socks were necessary to bring the patient back to a normal sinus rhythm.A second diagnostic coronary catheterization was performed to confirm the embolism was not longer present, and a venous return aortic balloon was placed to promote ventricular function.The patient remains hospitalized with severe neurological problems.No further patient complications have been reported as a result of this event.Additional incoming information indicated the patient suffered a complete block produced by an air thromboembolic collapse of the coronary arteries.The patient had brain damage produced by the thromboembolic air obstruction of brain arteries and their current status is 'critical.' it was noted the mapping catheter was inside the balloon catheter at the time of the initial blockage that occurred during the balloon advance.

• Brand Name: ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9367546
• MDR Text Key: 195105077
• Report Number: 3002648230-2019-00799
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 27771
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Date Device Manufactured: 08/16/2019
• 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): Hospitalization; Life Threatening; Required Intervention; Disability