MAUDE Adverse Event Report: MEDTRONIC INC. ADVANCED ARCTIC FRONT CRYOABLATION CATHETER

Lot Number 43930

Device Problems Material Puncture/Hole (1504); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/09/2018

Event Type  malfunction  

Event Description

During an electrophysiologic study, while ablating, the balloon stopped freezing, new cables and cryo machine rebooted.Unable to reestablish connection with cryo catheter.Catheter was removed and balloon was noted to be punctured.Procedure was completed with a new catheter.

• Brand Name: ADVANCED ARCTIC FRONT CRYOABLATION CATHETER
• Type of Device: CRYOABLATION CATHETER
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 7525416
• MDR Text Key: 108748732
• Report Number: MW5077296
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 43930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1