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	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files showed system notice 50014 indicating that ¿the balloon inflation pressure was not reached in time¿ on one application and system notice 50008 ¿the system has detected a software error and stopped the injection¿ on three other applications.Additionally, system notice 50012 ¿the refrigerant delivery path is obstructed¿ was also seen on a different application.At least 6 applications were performed with balloon catheter 2af283 with lot number 08327 on the date of the event.The reported system notices 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.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 system detected a software error and stopped the injection.The electrical umbilical cable was replaced without resolve.However, after checking other consumables, the notice could be cleared.It was then reported that a system notice was received indicating that the safety system detected a compromised outer vacuum.The balloon catheter was replaced and other consumables were reconnected and the electrical pins were checked without resolve.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
Product event summary: some console parts were returned and analyzed.Visual inspection of the patient board, compact flash, universal serial bus (usb) drive and patient board showed the products were intact with no apparent issues.The console was tested with a test balloon catheter and it passed the functional test.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: 8654689
• Report Number: 3002648230-2019-00405
• Device Sequence Number: 11220605
• Product Code: LPB
• UDI-Device Identifier: 00643169352476
• UDI-Public: 00643169352476
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 08/07/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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