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 Pulmonary Embolism (1498); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Nerve Damage (1979); Pulmonary Valve Stenosis (2024); Respiratory Distress (2045); Cardiac Tamponade (2226); Stenosis (2263); Vascular System (Circulation), Impaired (2572); Blood Loss (2597); No Code Available (3191)

Event Date 05/11/2020

Event Type  Injury  

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.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The model listed in the report is a representative of the model family, as there are no specifics listed.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 baseline age of the patients was 63 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.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿real-world safety of catheter ablation for atrial fibrillation with contact force or cryoballoon ablation.¿ journal of interventional cardia c electrophysiology.Published online 11may2020.Https://doi.Org/10.1007/s10840-020-00734-w.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter.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/manufacturers.There were patients who experienced tamponade/pericardial events requiring a pericardial drainage procedure, respiratory complications, stroke or other cerebral/pre-cerebral occlusion/stenosis, vascular access events, hemorrhage/blood transfusion, phrenic nerve complication, myocardial infarction, and pulmonary embolism.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.

• 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: 10164288
• MDR Text Key: 195459880
• Report Number: 3002648230-2020-00316
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• 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: 05/20/2020
• 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: 63 YR