MAUDE Adverse Event Report: MEDTRONIC, INC. FREEZOR MAX; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 239F3

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

Medtronic cryocath, #239f3, lot# 15156.Catheter stopped working during the case.It was removed and the case was completed with a different cryoablation catheter.

• Brand Name: FREEZOR MAX
• 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: 14955918
• MDR Text Key: 295496512
• Report Number: 14955918
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/27/2022

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 Model Number: 239F3
• Device Lot Number: 15156
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other