MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP 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); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: 2af284 (12372); product type: 0624-arctic front catheter.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, the temperatures were lower than expected and a full ablation was unable to be completed.The consumables were reconnected, the tank, coaxial umbilical cable, and electrical umbilical cable were replaced, and the auto connection box was bypassed without resolution.The case was aborted while the patient was under general anesthesia.The data files were later reviewed and a system notice was received indicating that the system detected a software error and stopped the injection.During a later servicing of the console, the temperature and power supply voltage were calibrated.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.Two patient data files were received and recorded on the reported date of the event.The first patient data file showed ten applications were performed using the console with serial number (b)(6) and catheter number one identified as (b)(6) with lot number 12372.The console's output data (pressure, preset pressure and flow) showed unexpected pressure and flow profiles during ablation at applications one, six, and nine with catheter (b)(6) with lot number 12372.The patient data file also showed three applications were performed using the console with serial number (b)(6) and catheter number two identified as (b)(6)with lot number 12362.The second patient data file showed 16 applications were performed using console with serial number (b)(6) and the catheter identified as (b)(6) with lot number 11332.The second patient file also showed system notice 50008 (the system detected a software error and stopped the injection) during the sixth application with catheter identified as (b)(6) with lot number 11332.The console output data (pressure, preset pressure and flow) showed unexpected pressure and flow profiles during ablation at applications one, three, four, eight, ten, eleven, thirteen, and fourteen with catheter identified as (b)(6) with lot number 11332.The fluctuations of pressure and flow had a plausible impact on the ablation temperature.In conclusion, the 50008 was confirmed through data analysis and the temperature issues were plausible.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 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: 19169299
• Report Number: 3002648230-2024-00166
• Device Sequence Number: 7938653
• Product Code: LPB
• UDI-Device Identifier: 00643169352476
• UDI-Public: 00643169352476
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female