MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 106A3

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that there is a problem with the system.Additionally, the pressures and flow were not as expected.The console was rebooted multiple times without resolve.The console was also rebooted multiple times without the cap and hose connected without resolve.The case was aborted and the patient was under general anesthesia.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files and some console parts were returned and analyzed.There was multiple power up messages observed in the data files.The console vacuum pump was returned and analyzed.Visual inspection showed that the valve was intact with no apparent issues.The console along with a test balloon catheter failed the performance test due to system notice 50022 ¿mechanical component error.¿ the product issues reported; a system notice indicating that there is a problem with the system and a system notice indicating a mechanical component error are not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRYOCONSOLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8968208
• MDR Text Key: 156722611
• Report Number: 3007566237-2019-01904
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: 00763000011147
• Combination Product (y/n): N
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other