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 Gas/Air Leak (2946)

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

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed system notice (b)(4) ¿refrigerant level is low.¿ the allegations of air embolism and st elevation could not be assessed through data analysis.Pending analysis of the physical product.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, there were issues with introducing the catheter.It was then reported that the patient subsequently experienced a transient st-elevation due to air embolism.It was noted that there was no medical intervention performed and there was no extended patient hospitalization.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter, 2af283 with lot number 43847, was returned and analyzed.Visual inspection of the balloon catheter showed that some pins were bent, thus the smart chip could not be verified, and the performance test could not be performed.Pressure test on the catheter did not show any leak through the catheter.Clinical issues were encountered during the case.There is no sufficient evidence that the balloon catheter caused the adverse events.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; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8347730
• MDR Text Key: 136609183
• Report Number: 3002648230-2019-00101
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 43847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2018
• 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