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	01/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 to a cryo ablation procedure, a system notice was received indicating that the refrigerant delivery path was obstructed.The tank, coaxial umbilical cable and the catheter were all replaced without resolve.The procedure was aborted while the patient was under general anesthesia.A service request was scheduled and the console was serviced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Event summary: the reported issue was that a system notice was received indicating that the refrigerant delivery path was obstructed¿.The bin files attached to the report were analyzed.The analysis confirmed that catheter model no.22446 serial no.(b)(4) was used on the date of the reported event for at least ten injections.The system message 50011 (the refrigerant delivery path is obstructed) was recorded at injections seven, eight and nine.The catheter was then replaced with catheter ref no.22446 serial no.(b)(4) and another injection was attempted triggering system message 50011 (the refrigerant delivery path is obstructed).The system was rebooted and another injection was attempted triggering again system message 50011 (the refrigerant delivery path is obstructed).A second system reboot was performed and for more injections were attempted with the same error message.No other error messages were recorded.The reported issue was verified through bin file analysis.The case was aborted.No patient complications were reported as a result of this event.The product issue reported (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.Console 106a3 (b)(4) is still in the field.No product was returned.In conclusion, the reported issue was confirmed through data analysis.
Additional Manufacturer Narrative
Correction.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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: 6279344
• Report Number: 3002648230-2017-00049
• Device Sequence Number: 1075669
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup,Followup
• Report Date (Section B): 02/07/2017

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: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/05/2017; 06/05/2017
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 03/02/2017; 06/05/2017; 09/29/2017; 09/29/2017
• 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