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

Model Number	106A3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the data files and mks valve from 106a3 cryoconsole with serial number (b)(4) were returned and analyzed.The data files showed at least four injections were performed with a non-returned balloon catheter on the date of the event with along with least one injection performed with a different non-returned balloon catheter on the date of the event.The data files confirmed system notice #50011 (refrigerant path is obstructed) upon the first injection on the date of event.The mks valve was then analyzed.Visual inspection showed that the product was intact with no apparent issues.When assembled to the console following a warmup time of 30 minutes, the performance test was completed without any system notice triggered.During a cooling performance test, the console failed and could not reach the required pressure in a controlled way.In conclusion, the console failed the returned product inspection due to the cooling test failure and possible leak, however, if the malfunction were to re-occur, it is not likely to cause or contribute to a death or serious injury.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.
Event or Problem Description
It was reported that during a cryoablation procedure, a system notice was received indicating that the refrigerant delivery path was obstructed.The console was rebooted, the coaxial umbilical cable, electrical umbilical cable, and "the catheter" were replaced without resolution.The coaxial umbilical cable port and coaxial cap were checked with no issues.The case was aborted while the patient was under general anesthesia.No patient complications have been reported as a result of this event.A service visit took place at a later date and the mks valve and low pressure regulator (lpr) were replaced to resolve the issues.

• Brand Name: CRYOCONSOLE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 10596771
• Report Number: 3002648230-2020-00506
• Device Sequence Number: 14404490
• Product Code: LPB
• UDI-Device Identifier: 00613994686077
• UDI-Public: 00613994686077
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other