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

Model Number 2AF282

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

Patient Problems Air Embolism (1697); Infarction, Cerebral (1771); Death (1802); Dysphagia/ Odynophagia (1815); Fatigue (1849); Fever (1858); Fistula (1862); Neurological Deficit/Dysfunction (1982); Sepsis (2067); Palpitations (2467); Shaking/Tremors (2515)

Event Date 03/25/2014

Event Type  Death  

Manufacturer Narrative

The date of death is not available at the time of this report; as there is no indication of specific serial number/patient information.Medtronic cryocath was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: atrioesophageal fistula complicating cryoballoon pulmonary vein isolation for paroxysmal atrial fibrillation.Circulation: arrhythmia and electrophysiology.2014;25(7): 787-792.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported that three days after a cryo ablation procedure, a patient experienced a sensation of "sticking" when swallowing that had resolved with medication.Two weeks after the procedure, the patient presented to the emergency room with fever, rigors, fatigue and palpations.Also, the patient had a neurological event with weakness of the right arm, facial dropping and slurred speech that resolved.The patient was transferred to the intensive unit in which their symptoms improved but did not completely resolve.A magnetic resonance imaging (mri) was completed, that revealed an acute infarction to the left frontoparietal region.An atrial esophageal fistula was suspected.A computerized tomography (ct) and electrocardiogram (ecg) scan were performed and air or micro bubbles were observed in the left atrium.Emergency surgery was conducted and a two millimeter fistula was located and repaired between the anterior esophagus and posterior left atrium near the left inferior pulmonary vein (pv).The patient left the operating room in a hemodynamically stable condition and a sepsis due to streptococcus constellatus resolved with antibiotics.A follow up ct scan was conducted and ischemic strokes were observed with a smaller right occipital stroke.It was noted that the patient made no meaningful neurological recovery and the patient's family decided to withdraw support.The patient expired two days later.An autopsy revealed no underlying esophageal disease with an intact repair of the fistula.

• Brand Name: ARCTIC FRONT 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6703921
• MDR Text Key: 79703353
• Report Number: 3002648230-2017-00313
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2AF282
• Device Catalogue Number: 2AF282
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 DA