MAUDE Adverse Event Report: MEDTRONIC, INC ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number 2AF284

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 02/09/2017

Event Type  malfunction  

Event Description

Computer code (outer balloon compromise).Rep called catheter in to medtronic report has been made.Manufacturer response for medtronic arctic front advance 28mm, medtronic (per site reporter).Rep called catheter in to medtronic report has been made.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6394645
• MDR Text Key: 69576731
• Report Number: 6394645
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2AF284
• Device Lot Number: 50147
• 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: 03/01/2017
• Event Location: Other
• Date Report to Manufacturer: 03/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR