It was reported that at the beginning of a cryo ablation procedure, when the sheath was inserted, the patient could no longer speak or move their left hand; it was suspected the patient had a transient ischemic attack (tia).The case was aborted.It was noted that the patient's hospital stay was extended.No further patient complications have been reported as a result of this event.
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Product event summary: the sheath, 4fc12 with lot number 85111, was returned and analyzed.Visual inspection of the sheath showed it was intact with no apparent issues.Deflection worked as per specification.Aspiration/flushing test did not show any air passing through the tube or expelled from the sheath distal tip.Multiple aspirations / injections were performed without air bubbles or leaks through the hemostatic valve when a test balloon catheter was introduced through the sheath.The hemostatic valve was leak tight.Clinical adverse events were encountered.In conclusion, there is no indication of relation of adverse event to the performance of the product.The sheath passed the returned product inspection as per specification.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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