MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	106A3
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The balloon catheter was replaced twice without resolution.It was later reported that the following day the console was vented and the tank was replaced.Test ablations were performed and there were no issues.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a cryo ablation procedure, a system notice was received indicating that the refrigerant delivery path was obstructed.The coaxial umbilical cable was replaced twice without resolve.The gas was replaced three times without resolve.The vacuum connection was changed without resolve.The case was aborted.The patient was under general anesthesia.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the service report was reviewed and the data files were returned and analyzed.Work performed included cleaning and disinfection of equipment.It was reported that the team presented "system notice 50011, the refrigerant delivery path is obstructed".The cylinder was changed and the line was purged because the obstruction was caused by the quality of the gas.The error was corrected.Functional tests and 5 catheter ablations were performed and the equipment worked correctly.The data files received included a patient file and a failure file.The patient file was showing catheter test applications, not catheter used during the case.The received failure file did not contain any failure records for the date of the event.In conclusion, the reported risk of the patient being under general anesthesia without full therapeutic effect cannot be assessed through review of the service report or data file analysis and the decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CRYOCONSOLE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20298954
• Report Number: 2182208-2024-04123
• Device Sequence Number: 8883421
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: 00763000011147
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 10/25/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/01/2024; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male