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	10/30/2017
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 cryo ablation procedure, a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection, and a system notice was received indicating that the system detected a high level of refrigerant flow during the system flush, and the system flush was stopped.The console was rebooted and the coaxial umbilical cable and balloon catheter were replaced, all without resolve.It was also reported that the temperature dropped rapidly and the pressure values were displaying abnormal behavior, including overshoots.The case was aborted while the patient was under general anesthesia.A field service visit 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: data files and field service engineering report (fser) were reviewed and analyzed.Data files confirmed a system notice indicating that the safety system detected a high level of refrigerant flow and stopped the injection (#50030) at multiple applications with the catheter on the date of event.Per the fser, the mks valve on the console was replaced.Also, the console was tested and observed with no overshoot irregularities.The console passed the inspection as per specification and deemed appropriate for clinical use.In conclusion, the reported pressure and temperature issue was confirmed through testing.The console failed the inspection by the field service engineer due to a defective mks valve.The product issue reported (#50030) 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: 7051809
• Report Number: 3002648230-2017-00641
• Device Sequence Number: 1159141
• Product Code: LPB
• UDI-Device Identifier: 00643169203150
• UDI-Public: 00643169203150
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/19/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 12/19/2017
• 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