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

Model Number	106A3
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: field service was carried out on the console.There was an indication of excessive humidity in the coolant tanks.The reported symptoms were reproducible in initial testing.The console was vented, flaw path evacuated, and the tank was replaced.Additionally, a preventative maintenance was carried out.No parts were replaced.During the preventative maintenance, contaminated gas was eliminated from the console.No uncorrectable faults were noted, the console was returned to service.In conclusion, a field service and preventative maintenance were carried out, and the decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.There is no indication of a relation of the adverse event to the performance and malfunction of the product.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 and catheter were replaced without resolution.The case was aborted while the patient was under general anesthesia. test ablations were later performed, and a system notice was received indicating that the system was unable to initiate the system flush.It was noted that the tank was recently replaced.The tank was replaced, the console was vented, and the coaxial cap was temporarily removed from the console without resolution.No further patient complications have been reported as a result of this event.
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.

• 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: 19234687
• Report Number: 2182208-2024-01913
• Device Sequence Number: 14869234
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: 00763000011147
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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 Sex: Unknown