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); Stroke/CVA (1770); Embolism (1829); Fistula (1862); Nerve Damage (1979); Paresis (1998); Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024); Tissue Damage (2104); Cardiac Tamponade (2226)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Medtronic 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.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The overall baseline gender/age characteristics is male/61 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: catheter ablation of atrial fibrillation in patients with heart failure with reduced ejection fraction: real world experience from six european centers.Journal of cardiovascular electrophysiology.2019; 30(8):1270-1277.Doi:// 10.1111/jce.14027.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following patient complications/malfunctions while using a cardiac cryoballoon ablation catheter: there were patients with cardiac tamponade, transient ischemic attack (tia), stroke, transient phrenic nerve palsy, ¿major¿ vascular complications, ¿other complications,¿ esophageal fistula, gastroparesis, esophageal ulcer, non-access related bleeds, bradyarrhythmic ¿complications,¿ anaphylaxis, transient myocardial stunning, pulmonary vein stenosis, air embolism, and acute pulmonary edema.There was no indication of treatment/resolution.The status/location of the catheter is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: further review prompted a change in the patient codes.The change is reflected in this report.Additional information: report source.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 8950182
• MDR Text Key: 157137992
• Report Number: 3002648230-2019-00630
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR