MAUDE Adverse Event Report: MEDTRONIC INC MEDTRONIC FREEZOR XTRA ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Lot Number 31626

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2020

Event Type  malfunction  

Event Description

Ablation catheter would not start up once placed into the sheath.The ablation signal would not appear on the screen when placed into the sheath.Catheters switched out.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC FREEZOR XTRA ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC INC
• MDR Report Key: 9775007
• MDR Text Key: 181751781
• Report Number: MW5093416
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 31626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1