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

Model Number 2AF234

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

Patient Problems Hematoma (1884); Pseudoaneurysm (2605)

Event Date 11/14/2019

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 the unique product serial numbers, a one to one correlation could not be made, the manufactured date cannot be established, and it is unknown if this was previously reported.Multiple patients were noted in the article.The baseline gender/age/race characteristic is male/(b)(6) years/caucasian.If additional information is received, a supplemental report will be submitted accordingly.Referenced article: a randomized comparison of manual pressure versus figure-of-eight suture for hemostasis after cryoballoon ablation for atrial fibrillation.Journal of cardiovascular electrophysiology 2019 dec;30(12):2806-2810 doi: 10.1111/jce.14252.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding a cryoablation balloon.The authors described cases where three patients developed a minor hematoma.There was no indication that intervention was required.One patient developed a pseudoaneurysm, which was diagnosed thirty days post ablation.The patient was managed with compression and no additional intervention was required.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: 11007812
• MDR Text Key: 221453544
• Report Number: 2182208-2020-03283
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2AF234
• Device Catalogue Number: 2AF234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• 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): Required Intervention
• Patient Age: 62 YR