MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number 2AF284 |
Device Problems
Device Contamination with Body Fluid (2317); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, a system notice was received indicating that there is a problem with the system.The case was switched to a backup console.The console was vented prior to use.The low pressure regulator (lpr) was stuck at one value.The tank was opened.Another system notice was received indicating that the refrigerant delivery path was obstructed.The console was switched to radiofrequency (rf) ablation.The case was completed with radiofrequency.A field service for the first console took place.A system notice was received indicating that the refrigerant delivery path was obstructed.The system was flushed, and a new tank of gas was installed.Visual inspection showed a small amount of blood in the coaxial port.The binary files showed a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.In addition to a system notice indicating that there was a problem with the refrigerant port.The console was serviced appropriately.Also, a field service visit took place for the second console.A system notice was received indicating that the refrigerant delivery path was obstructed.The system was flushed.During visual inspection a large amount of blood was observed in the coaxial port.The binary files showed a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.In addition to a system notice indicating that there was a problem with the refrigerant port.Test injections showed decreased flow, indicating that blockage is present.The console could not be serviced and was removed.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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