MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	106A3
Medical Device Problem Codes	Protective Measures Problem (3015); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cryo ablation procedure using the electrophysiology (ep) catheter, a system notice was received indicating that the system detected a temperature drop during the system flush, and the system flush was stopped.There was no saline flush during the procedure, and the system flush could not be started.The operator reported changing the catheter, electrical umbilical, and auto connection box without resolution.The radiofrequency generator was off.Technical services ensured the catheter tip was out of the sheath and in contact with blood, confirmed the console was on its own outlet, and suggested turning off a warming device.A backup console was obtained and functioned normally.Test ablations were performed successfully, and data files were reviewed by technical services.Calibration of temperatures was performed twice, and both final and extended self tests were completed per manufacturer¿s specifications.Technical services noted pressure mismatches characteristic of an injection proportional valve problem and recommended service, including replacement of the injection proportional valve and checking temperature calibration.Technical services also discussed that the system notices were likely caused by external device interference in the lab and recommended using a grounding cable and a different outlet.It was also suggested that warm sterile saline could be used to initiate and complete the system flush outside of the body if issues persisted.Subsequently, while using the backup console, a system notice indicated that the safety system detected a high level of refrigerant flow and stopped the injection, with intermittent notices.No consumables were changed.Technical services explained that covering the exposed catheter shaft with a wet sterile towel could help reduce these notices and recommended test injections.Bin files were provided, and technical services confirmed repeated system notices but noted that on a successful ablation, the console controlled pressure and flow normally.The case was aborted due to these device/system issues.The patient was under general anesthesia.No 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 CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22506228
• Report Number: 3002648230-2025-00636
• Device Sequence Number: 15769209
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: (01)00763000011147(11)220101
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: 06/30/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2022
• 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