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	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 cryoablation procedure, a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.It was determined that the system notice was received due to a broken mks valve.A field service visit was scheduled for a later date.The case was aborted and the patient was under general anesthesia.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Event summary: the patient data files confirmed system notices received indicating that the safety system detected a high level of refrigerant flow and stopped the injection (50029) at applications two and three.A second system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection (50030) at applications one, four, five, six, seven and eight for catheter 2af284 / 94669-45 on the date of event.Bin files also showed at least nine applications were performed with this catheter.Console 5m0142 was serviced.The mks valve was found open.The mks was replaced and issue was resolved.The reported issue does not indicate console¿s manufacturing related defect.In conclusion, the reported issue has been confirmed by field service engineering.Console 5m0142 failed the inspection due to a defective mks proportional valve.The product issue reported ( system notices 50029 <(>&<)> 50030) 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.
Additional Manufacturer Narrative
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: 6560643
• Report Number: 3002648230-2017-00220
• Device Sequence Number: 867447
• Product Code: LPB
• UDI-Device Identifier: 00643169352476
• UDI-Public: 00643169352476
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/07/2017

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: 04/18/2017
• Supplement Date Received by Manufacturer: 06/07/2017; 06/07/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 07/03/2017; 10/03/2017
• 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