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 Air Leak (1008)

Patient Problems Air Embolism (1697); Chest Pain (1776); Anxiety (2328)

Event Date 04/07/2016

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure after insertion of the sheath using over the guide wire exchange, the sheath was flushed and aspirated without any reported issues.A competitor pigtail catheter was inserted into the left atrium for pulmonary vein angiogram.The balloon catheter was prepped and the mapping catheter was inserted into the balloon catheter and the system was inserted into the patient via the sheath.When the balloon catheter was at the level of the ostium of the left superior pulmonary vein (lspv) there was a white, circular structure observed on flouroscopy.The balloon and mapping catheters were removed from the body but the structure remained.An intervention radiologist was called in to assist and the structure observed was noted to be air which was aspirated back (estimated to be about five milliliters) using the side port of the sheath which remained in the left atrium.Upon discovery of the air the patient became restless, agitated and complained of chest pain.Vital signs and neurological status remained stable throughout the discovery and removal of the air.The mapping and balloon catheters were replaced and the procedure was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device, balloon catheter 2af284 with lot number, and data files were returned and analyzed.The data files did not show any notices or issues.Visual inspection of the catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was not used.The reported air ingress could not be reproduced.Multiple aspirations and injections were performed without air bubbles or leaks.In conclusion, the balloon catheter passed the returned product inspection.A clinical issue was encountered during the procedure.

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 CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5593505
• MDR Text Key: 43192820
• Report Number: 3002648230-2016-00157
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 13472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• 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): Life Threatening; Required Intervention