MAUDE Adverse Event Report: MEDTRONIC, INC.; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number 5M0384

Device Problems Difficult to Open or Close (2921); Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Cryoablation machine was showing an error when doctor went to use it for ablation.Passed pre-procedure test.Error was indicating "high refrigerant flow" at time of intended use.Staff, biomed and product rep via phone attempted to troubleshoot without resolution.The procedure could not be completed.Unit was serviced by manufacturer and was found to have a valve that was "stuck open" therefor not regulating flow.This unit was up to date on service (most recently in march) and was described as unpreventable wear and tear.

• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13059319
• MDR Text Key: 282625746
• Report Number: 13059319
• Device Sequence Number: 1
• Product Code: LPB
• 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: 12/15/2021

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 Catalogue Number: 5M0384
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5110 DA
• Patient Sex: Female
• Patient Weight: 59 KG