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

Model Number	106A3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
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 cryo ablation procedure, the flow was not within the expected range, then a system notice was received indicating that the refrigerant delivery path was obstructed.The coaxial umbilical cable was reconnected without resolve.The coaxial umbilical cable was replaced without resolve.It was noted that no debris was seen in the coaxial port.The tank was replaced without resolve.The balloon catheter was replaced 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.Additional information reported that a field service visit took place on a later date, the flow meter was out of tolerance and it was adjusted.The console was serviced as appropriate.
Additional Manufacturer Narrative
Event summary: patient data files showed at least fourteen applications were performed with catheter 2af284/ 87484 without any issue on the date of the event.The data files confirmed system notice (#50011) indicating that the refrigerant delivery path was obstructed in the beginning of the ablation of the applications two through five with catheter 2af284/ 87484.Bin files showed at least five applications were performed with this catheter on the date of the event.The case was aborted while the patient was under general anesthesia.In conclusion, the reported system notice (#50011) was confirmed through data analysis.The product issue reported (system notice 50011) 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: 8096909
• Report Number: 3002648230-2018-00866
• Device Sequence Number: 11482952
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/20/2018

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: 10/30/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/20/2018
• 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
• Patient Age: 65 YR