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

Model Number 106A3

Device Problems Gas/Air Leak (2946); Material Integrity Problem (2978); Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files and mks valve m733332b001, solenoid valve (s1) 12000-s343, and valve board 11000-s362-0 from 106a3 cryo console with serial number 5m0700 were returned and analyzed.The data files showed at least one application was performed with afapro28 balloon catheter with lot 22265.The data files also confirmed multiple occurrences of system notice 50022; indicating a mechanical component error, 50024; indicating that there was a problem with the refrigerant port, and 50013; indicating that the refrigerant level was too low to continue.Visual inspection of the mks valve and s1 valve showed that the valves were intact with no apparent issues.The console along with the balloon test catheter failed the performance test due to persistent system notice 12221, indicating that the system detected a high level of refrigerant flow during the system flush, and the system flush was stopped.During the cooling performance test, the console failed to reach the required pressure.During ablation, the s1 valve was is not closing as expected.The valve s1 was electrically disconnected during ablation.Pressure and flow readings showed the valve was leaking.The valve board visual inspection showed that the board was intact with no apparent issues.The valve board was assembled to the console.The console along with returned mks and s1 valves and valve board failed the performance test due to system notices 50024 indicating there is a problem with the refrigerant port and 50022 indicating a mechanical component error.The coaxial umbilical cable was disconnected from the catheter, and nitrous oxide was then observed ejecting from the distal end of the coaxial umbilical.Pressing the continue button in the system notice window didn't reset the failure.Pressing the stop button manually didn't stop the injection as the injection was already terminated by the safety system, the console reacted as expected.The safety system detected the failure and accordingly reacted and terminated the injection by closing injection valves mks and s1, and by opening the vent valve s6.Given the valves mks and s1 are both in a failure state, the refrigerant in a liquid-state is evacuated towards the scavenging through valve s6.The excess of refrigerant caused the formation of ice on the vent valve s6.In conclusion, the reported system notices 50024 and 50022 were been confirmed through testing and data analysis.The mks valve failed the returned product analysis due to system notice 12221 and 50022 and the valve not responding properly to pid control.The s1 valve failed the returned product analysis due to system notice 50024 and the valve not responding properly when de-energized.The valve board passed the returned product inspection as per specification.The 203cx coaxial umbilical cable failed visual inspection due to broken tip and bent arm.Most likely the damage occurred during attempt by the user to stop refrigerant escape from the white female coaxial connector.The reported left-hand injury due to refrigerant ejecting from the female coaxial connector at the console most likely was the result of the simultaneous failure of the injection valves mks and s1 and the user disconnecting the coaxial umbilical from the console.The reported issue was resolved by mks, s1 valve, and valve board replacement.If the malfunction were to re-occur, it is not likely to cause or contribute to a death or serious injury.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the coaxial umbilical cable and electrical umbilical cable were removed from the console, and nitrous oxide coolant ejected from the console coaxial port.The biomedical engineer attempted to reconnect the coaxial umbilical cable to stop the coolant leak, and fingers on the left hand were injured by the coolant.The fingers were warmed in water and the procedure continued.The case was completed with radiofrequency.The biomedical engineer visited the outpatient emergency department and was prescribed medicine.The next day, the biomedical engineer reported pain and light blistering.No further patient complications have been reported as a result of this event.

• Brand Name: CRYOCONSOLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9974263
• MDR Text Key: 194612890
• Report Number: 3002648230-2020-00227
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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: 03/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention