It was reported that during a cryo ablation procedure, a system notice was received indicating that the system did not recognize the catheter and a system notice was received indicating that the safety system detected a compromised outer vacuum.The electrical umbilical cable and auto connection box were both replaced twice without resolution.The balloon catheter was connected directly to the console which did not resolve the issues.The balloon catheter was replaced which did not resolve the issues.The console was restarted, the power supply replaced, the knob at the end of the balloon catheter was tightened, and the high powered equipment was turned off.The case was completed with radiofrequency (rf). no patient complications have been reported as a result of this event.
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Product event summary: the 4fc12 with lot number 0011640157 was returned and analyzed.Visual inspection prior to disassembly and functional testing was performed on the shaft, handle, and dilator.The inspection identified a shaft kink/twist at approximately 12 inches from the tip.Visual inspection of the handle area was performed and identified a missing identification blue label on the handle.The dilator was inserted into the sheath and retracted several times, without any friction.The dilator was snap-locked to the sheath and was tight.Visual inspection and magnifying with a high-resolution microscope showed the dilator luer and tip were intact without any issue.In conclusion, the sheath failed the returned product inspection due to a kink/twist on the shaft and due to the identification label missing from the handle.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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