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

Model Number	106A3
Medical Device Problem Codes	Infusion or Flow Problem (2964); Protective Measures Problem (3015); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
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
It was reported that during a cryo ablation procedure, multiple system notices were received indicating that the refrigerant delivery path was obstructed.The console was rebooted, coaxial umbilical cable and balloon catheter replaced and console was vented without resolve.The coaxial port was noted to be clear.The high pressure regulator (hpr) values were not as expected.The coaxial umbilical cable was replaced again without resolve.The flow was not as expected during the system flush.Additionally, there was a clicking sound coming from then non-tank side door.The case was aborted, the patient was under general anesthesia.A service was recommended. 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.
Additional Manufacturer Narrative
Product event summary: the data files containing four patient files were returned and analyzed.Patient file number one showed four applications were performed using a catheter identified as (b)(6) of lot number 16287.Patient file number two showed three applications were performed using catheter number one identified as (b)(6) of lot number 16287.Patient file number two showed one application was performed using catheter number two identified as (b)(6) of lot number 16159.Patient file number three showed two applications were performed using a catheter identified as (b)(6) of lot number 16159.Patient file number four showed one application was performed using a catheter identified as (b)(6) of lot number 16259.Patient file number one showed system notice 50011 (the refrigerant delivery path is obstructed) during transition at application one, two, three, four.Patient file number two showed system notice (b)(4) (the refrigerant delivery path is obstructed) during transition at applications one and two with catheter (b)(6) of lot number 16287 and number four with catheter (b)(6) of lot number 16159.Patient file number three showed system notice (b)(4) (the refrigerant delivery path is obstructed) during transition at application number one and two.Patient file number four showed system notice (b)(4) (the refrigerant delivery path is obstructed) during transition at application number one.The reported loud noise from conso le issue could not be assessed through data analysis.The issue is not recorded to the data files.A field service was carried out and the system notices were confirmed through data analysis.The proportional valve (pv) was replaced and a (b)(4) (an error message was received indicating that there was a peripheral interface (spi) acknowledge timeout) system notice was received.The nipple filter was replaced without resolve.The valve board was then replaced to resolve the issue.The preventative maintenance was completed without further issues.In conclusion, the reported system notices were confirmed through data analysis.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.The reported loud noise from console issue could not be assessed through data analysis, the physical console was not returned and aborted under general anesthesia cannot be assessed through data analysis.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: 19687702
• Report Number: 3002648230-2024-00303
• Device Sequence Number: 7137395
• Product Code: LPB
• UDI-Device Identifier: 00643169352476
• UDI-Public: 00643169352476
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 08/26/2024

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: 07/01/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 08/14/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/13/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female