MAUDE Adverse Event Report: MEDTRONIC ARTIC FRONT ADVANCE; CRYOABLATION CATHETER

Model Number 2AF284

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 06/27/2016

Event Type  Injury  

Event Description

During cryoablation, balloon catheter showed "outer balloon vacuum compromised".Per recommendation of rep and md, catheter was removed and another one was opened.

• Brand Name: ARTIC FRONT ADVANCE
• Type of Device: CRYOABLATION CATHETER
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5818687
• MDR Text Key: 50412657
• Report Number: MW5063607
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2017
• Device Model Number: 2AF284
• Device Lot Number: 06494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 94