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

Model Number 2AF284

Device Problem Material Rupture (1546)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/06/2021

Event Type  Injury  

Event Description

During ablation balloon ruptured, resulted in tamponade requiring further surgery.

• Brand Name: MEDTRONIC ARCTIC FRONT ADVANCE
• Type of Device: CRYOABLATION CATHETER
• Manufacturer (Section D): MEDTRONIC; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11736860
• MDR Text Key: 247892207
• Report Number: 11736860
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 01349
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2021
• Distributor Facility Aware Date: 04/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR