MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP 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 Bacterial Infection (1735); Stroke/CVA (1770); Nerve Damage (1979); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Respiratory Failure (2484); Pericardial Effusion (3271)

Event Date 01/07/2021

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.The baseline gender/age characteristics is male/64 years old.Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method.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: "cryoballoon vs radiofrequency ablation of atrial fibrillation: insights from the veterans healthcare system" journal of interventional cardiac electrophysiology.2020.Https://doi.Org/10.1007/s10840-020-00927-3.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 cryoablation procedure: four (4) patients developed pericardial effusions, two (2) patients developed tamponade that required drainage, one (1) patient experienced transient ischemic attack (tia)/stroke, two (2) patients developed non-vascular bleeding, one (1) patient experienced respiratory failure, three (3) patients experienced phrenic nerve palsy (pnp) that all recovered by their one-year follow up.The status of the catheters is unknown.Follow up is being conducted for additional information on the catheters.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 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: 11333028
• MDR Text Key: 231998217
• Report Number: 3002648230-2021-00078
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 64 YR