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

Model Number AFAPRO28

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

Patient Problems Bradycardia (1751); Nerve Damage (1979); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446); Pericarditis (4448)

Event Date 01/01/2020

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.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique manufacturer/device serial numbers.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.The baseline gender/age characteristic is male/68 years old.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: concomitant pulmonary vein and posterior wall isolation using cryoballoon with adjunct radiofrequency in persistent atrial fibrillation journal of the american college of cardiology doi.Org/10.1016/j.Jacep.2020.08.016.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 procedure.The authors discussed cases where a patient developed persistent phrenic nerve palsy, one patient developed bradycardia and needed a pacemaker, there was a case of heart failure exacerbation, a case of pericarditis, a case of pericardial effusion, and one groin vascular complication.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 PRO 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: 11041265
• MDR Text Key: 222623373
• Report Number: 2182208-2020-03377
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• 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: 68 YR