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	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files showed five applications were performed with balloon catheter afapro28 with lot number 57857.A system notice of 50024, indicating that there was a problem with the refrigerant port was confirmed through data analysis.Additionally, the power up message of 11200, indicating that there is a problem with the system was confirmed through data analysis.In conclusion, the system notice of 50024, indicating that there was a problem with the refrigerant port, and the system notice of 11200, indicating that there is a problem with the system, 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 there was a problem with the refrigerant port.The console was rebooted without resolution.A system notice was received indicating that there is a problem with the system.Suction was observed when the coaxial umbilical cable was removed from the console.Also, an abnormal pressure was observed.So, the system was vented, and the coaxial cap was removed without resolution.The system was rebooted again which appeared to resolve the issue with the pressure at the time.However, the pressure reappeared again, and, a system notice was received indicating that there was a problem with the refrigerant port once again.The case was aborted with the patient under general anesthesia.A service visit took place at 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: the pressure transducer pt1:12002-165 and analog board gen v universal 11000-s130 from 106a3 cryo console with serial number (b)(4) were returned and analyzed.Visual inspection of the pressure transducer showed that the transducer was intact with no apparent issues.Assembled to the console and following a warm up time of 30 minutes, the console along with the test catheter passed the mechanical performance test as per specification.On cooling performance test with balloon test catheter the pressure transducer pt1 is reading the actual pressure.The flow reading corresponds to the displayed pressure.Visual inspection of the analog board showed that the board was intact with no apparent issues.Assembled to the console and following a warm up time of 30 minutes, the console along with freezor xtra and balloon test catheter passed the mechanical performance test.In conclusion, the pressure transducer and analog board passed the visual and performance tests as per specification.If the malfunction were to re-occur, it is not likely to cause or contribute to a death or serious injury.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: 9750968
• Report Number: 3002648230-2020-00116
• Device Sequence Number: 2929598
• 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): 03/27/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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