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 Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Cellulitis (1768); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Tachycardia (2095)

Event Date 08/09/2014

Event Type  Injury  

Event Description

Cryoablation procedure performed (b)(6) 2014.On (b)(6) 2014, patient diagnosed with atypical atrial flutter with rvr(rapid ventricular response).Patient presented to urgent care with left arm cellulitis.Found to be tachycardic with complications for atrial fibrillation with rapid ventricular rate.Symptoms of mild shortness of breath with exertion began when admitted.Ecg confirmed diagnosis.Patient hospitalized and cardioverted.Cellulitis also treated with antibiotics.Event resolved on (b)(6) 2014.The patient's ecg on the day of discharge ((b)(6) 2014) indicated first degree av block.Follow up ecg on (b)(6) 2014 also indicated first degree av block.No action was taken to treat the first degree av block.

Manufacturer Narrative

The device is not available for investigation; it was discarded after the procedure.There was no indication of product malfunction.

Manufacturer Narrative

The device is not available for investigation; it was discarded after the procedure.There was no indication of product malfunction.Bin files were reviewed and showed that 16 injections were performed with the catheter without any issue or system notice message.

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; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 4101449
• MDR Text Key: 18037253
• Report Number: 3002648230-2014-00155
• 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: Study,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 72639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided; 10/30/2014
• Supplement Dates FDA Received: 11/03/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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
• Patient Age: 00067 YR
• Patient Weight: 76