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

Model Number	106A3
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: data files were returned and analyzed.Data files confirmed that a balloon catheter was used on the date of the event for at least 8 injections on the console.Also, system notices were confirmed indicating that the vacuum is disabled due to a problem with the coaxial umbilical cable at injection 3 of 8 ((b)(4)) and the safety system had detected a high level of refrigerant flow ((b)(4)) and stopped the injection at injection 5 of 8.In conclusion, the product issue reported ((b)(4)) 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.The console remains in the field.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, a system notice was received indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable.It was noted that a ¿snap¿ was heard and the connection between the balloon catheter and coaxial cable was frozen.The coaxial umbilical cable was replaced.At the next freeze, the ¿flashing coaxial connection¿ was observed on the screen.Additionally, a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The balloon catheter was replaced.Flow issues continued and the coaxial umbilical was replaced and the console was rebooted without resolve.The case was aborted while the patient was under general anesthesia.No patient complications have been reported as a result of this event.

• 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: 6384767
• Report Number: 3002648230-2017-00110
• Device Sequence Number: 317008
• Product Code: LPB
• UDI-Device Identifier: 00613994775955
• UDI-Public: 00613994775955
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/15/2016

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1