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 Problem Undesired Nerve Stimulation (1980)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that during a cryo ablation procedure, a palpation was performed that confirmed that the patient experienced phrenic nerve injury.A double stop was conducted and the patient's condition improved.It was unknown at this time if the patient recovered prior to discharge.The procedure was completed with the cryo console and no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: data files were returned and analyzed.Data files showed that at least 17 injections were performed with the catheter without any issue on the date of the event.The catheter was not returned for investigation.This was a clinical issue encountered during the procedure.In conclusion, there was no indication of product malfunction and no product was returned.

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 H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5451338
• MDR Text Key: 38695904
• Report Number: 3002648230-2016-00056
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2016

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: 10/27/2016
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 93592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided; 03/09/2016
• Supplement Dates FDA Received: 03/22/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2015
• 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