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

Model Number AFAPRO28

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Event Description

Alarm from console #50002 "electrical component failure".Trouble shooting performed by rep, cables changed, and after case a test balloon was used.It was determined that the problem was with the balloon that was used for patients cryo ablation.Case was finished without incident, but balloon failure caused delay of care.

• Brand Name: ARCTIC FRONT ADVANCE PRO
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10401004
• MDR Text Key: 202733495
• Report Number: 10401004
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2020,07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFAPRO28
• Device Lot Number: 54296
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 92