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

Model Number 2AF283

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); ST Segment Elevation (2059)

Event Date 09/09/2016

Event Type  malfunction  

Event Description

It was reported that during a cryo ablation procedure air introduction into the patient's left atrium was alleged.Procedure outcome was unknown at this time.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter and data files were returned and analyzed.Data files showed at least 14 injections were performed with the returned catheter without any issues on the date of the event.Visual inspection of the catheter showed that the inner balloon had blood.Pressure test and a dissection revealed a leak through the 10 psi check valve at the y-block and a leak through one of the pull wire guides in the y-block inside the handle.Also, there was a leak through the guide wire lumen.A dissection showed a guide wire lumen breach at 1.38 inches from the tip and no traces of blood at the handle.A clinical issue of st elevation was encountered during the procedure.In conclusion, the reported issue of air ingress was confirmed through testing.The catheter failed the return inspection due to a guide wire lumen breach/kinked.Also, there was a leak through one of the pull wire guides in the y-block and 10psi check valve.

Event Description

It was further reported that air was not visible and "just the st elevation was observed on the ecg that took some time to resolve".No further patient complications have been reported as a result of this event.

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: 6010931
• MDR Text Key: 56820276
• Report Number: 3002648230-2016-00428
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2018
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 35669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/01/2016
• Supplement Dates FDA Received: 11/08/2016; 12/19/2016; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2016
• 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
• Treatment: 4FC12 SHEATH
• Patient Outcome(s): Other