MAUDE Adverse Event Report: MEDTRONIC ARTIC FRONT; CRYOBALLOON

Model Number REF# 2AFAST28

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 01/20/2016

Event Type  malfunction  

Event Description

Cryo afib ablation was in progress.Medtronic cryo balloon 2 a fast# 28 utilized along with achieve catheter through a flexcath located in patients left atrium.The balloon catheter developed a kink that placed the portion that runs through the balloon at a 90 degree angle.The entire system sheath, balloon, and achieve were safely removed.

• Brand Name: ARTIC FRONT
• Type of Device: CRYOBALLOON
• Manufacturer (Section D): MEDTRONIC; minn MN 55432 5604
• MDR Report Key: 5398044
• MDR Text Key: 37090980
• Report Number: MW5059760
• Device Sequence Number: 1
• Product Code: OAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2016

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: 07/17/2016
• Device Model Number: REF# 2AFAST28
• Device Lot Number: 49049
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 48