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); Nerve Damage (1979); Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024); Tissue Damage (2104); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 12/30/2019

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.Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers.The overall baseline gender characteristics is male; the age of the patients was 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: ¿impact of type-2 diabetes mellitus on the outcomes of catheter ablation of atrial fibrillation (european observational multicentre study).¿ am j cardiol.2020 mar 15;125(6):901-906.Doi: 10.1016/j.Amjcard.2019.12.037.Epub 2019 dec 30.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications during a procedure using a cryoballoon ablation catheter: there were patients who experienced cardiac tamponade, transient ischemic attack (tia), stroke, transient phrenic nerve palsy (pnp), ¿major¿ vascular complications, esophageal fistulas, gastroparesis, esophageal ulcer, bleeding, arrhythmia, anaphylaxis, transient myocardial stunning, pulmonary vein stenosis, air embolism, and acute pulmonary edema.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The status/location of the cryoballoon 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 report type.The change is reflected in this report under section h1 - type of reportable event.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: 10059166
• MDR Text Key: 191137062
• Report Number: 3002648230-2020-00275
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 61 YR