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	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files showed at least six applications were performed with balloon catheter afapro28 with lot, 00947.A system notice of 50032, indicating that the safety system detected a compromised outer vacuum and a system notice of 50011, indicating that the refrigerant delivery path was obstructed, were confirmed through data analysis.The console 106a3 with serial number (b)(4), failed the inspection due to a blocked female coaxial port with a broken coaxial tip and o-ring.In conclusion, the system notice of 50032, indicating that the safety system detected a compromised outer vacuum and a system notice of 50011, indicating that the refrigerant delivery path was obstructed, 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.
Event or Problem Description
It was reported that the console was having issues.Testing was performed at a later date.System notices were received indicating that the refrigerant delivery path was obstructed.The system was vented.There was a dip in flow and a system notice was received indicating that the refrigerant delivery path was obstructed.The coaxial port was blocked.The o-ring and tip were removed, resolving the issues.The coaxial cap was also broken.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: 9829313
• Report Number: 3002648230-2020-00156
• Device Sequence Number: 2896248
• Product Code: LPB
• UDI-Device Identifier: 00613994686077
• UDI-Public: 00613994686077
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 03/02/2020
• Initial Report FDA Received Date: 03/13/2020
• 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