MAUDE Adverse Event Report: MEDTRONIC, INC. ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF284

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

Patient Problems Nerve Damage (1979); Paresis (1998); Blood Loss (2597); Pericardial Effusion (3271)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.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.Of note, multiple patient were noted in the article however, a one to one correlation could not be made without unique manufacturer/device serial numbers.The baseline gender/age characteristic is male/67 years old.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Long-term durability of posterior wall isolation using the cryoballoon in patients with persistent atrial fibrillation: a multicenter analysis of repeat catheter ablations journal of interventional cardiac electrophysiology 2020;10.1007 doi.Org/10.1007/s10840-020-00887-8.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding cryoablation.The authors discussed cases where the luminal esophageal temperature fell, and the procedure was terminated without any detectable long-term sequelae.There were patients that developed gastroparesis, groin vascular complications, pericardial effusion, persistent phrenic nerve palsy, and retroperitoneal bleed.The disposition of the products is not known.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10814164
• MDR Text Key: 216366200
• Report Number: 2182208-2020-02721
• 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: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• 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
• Patient Age: 67 YR