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 Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Infarction, Cerebral (1771); Fistula (1862); Hematoma (1884); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/01/2018

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.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/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with manufacturers/methods/unique lot numbers/adverse events.The model listed in the report is a representative of the model family, as there is no specific model listed.The baseline gender/age of the patients represented in the article is male/(b)(6).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: ¿uninterrupted direct oral anticoagulant and warfarin administration in elderly patients undergoing catheter ablation for atrial fibrillation a comparison with younger patients.¿ j am coll cardiol ep 2018;4:592¿600.Https://doi.Org/10.1016/j.Jacep.2018.02.013.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following possible patient complications while using a cryoablation balloon: there were patients with cerebral infarctions, transient ischemic attack (tia), cardiac tamponade, arteriovenous fistula requiring surgery, bleeding hematoma requiring blood transfusion, pericardial effusion requiring blood transfusion, puncture site bleeding or hematoma, pericardial effusion without tamponade, and arteriovenous fistulas without intervention.There was medical/surgical intervention taken for many of the adverse events there were also two patients each with "continuous bloody phlegm," and "continuous hematuria"; there was no indication of treatment/resolution for these two patients.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique manufacturer/product serial numbers/adverse events.Further follow up did not yet yield any additional information.The status/location of the cryoballoon is unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7674330
• MDR Text Key: 113590379
• Report Number: 3002648230-2018-00469
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• 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: 08/08/2018
• 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: 74 YR
• Patient Weight: 60