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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 safety system detected a high level of refrigerant flow and stopped the injection.The coaxial umbilical cable was unplugged without resolve.The coaxial cable was replaced and the console was rebooted, and a system notice was received indicating that there is a problem with the system.Additionally, an unknown system notice was received several times indicating a failure of the flow curve test (fct).A power up test was then manually started without resolve.The case was aborted, and the patient was under general anesthesia.A field service took place on a later date, and the console was serviced as appropriate.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files for the data of the event and field service engineering report (fser) were returned and analyzed.The files showed two applications were performed with the balloon catheter, and confirmed system notice 50030 (the safety system has detected a high level of refrigerant flow and stopped the injection) was received with both applications.A power up notice 11200 was also triggered eight times on the date of the event indicating excessive flow.As per the fser, replacing the watchdog (wd) board resolved the issue.The product issue reported (system notices 50030 and 11200) is 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
• 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: 7139602
• Report Number: 3002648230-2017-00712
• Device Sequence Number: 1300891
• Product Code: LPB
• UDI-Device Identifier: 00613994775955
• UDI-Public: 00613994775955
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/09/2018
• 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