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Model Number 105-5056 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/04/2022 |
Event Type
Injury
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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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Medtronic received a report that the distal part of the marathon catheter ruptured during onyx injection.The patient was undergoing treatment for a arteriovenous malformation (avm) embolization.The patient's vessel tortuosity was normal.It was reported that the onyx liquid embolic had been injected smoothly since the start of injection, and the injection was continued without any problems even after switching from onyx 34 to 18.The catheter suddenly broken, and the procedure was finished and the catheter was removed.At that time, complications such as bleeding/infarction were not observed.Per the surgeon a little resistance was felt during injection.There had been no resistance during delivery.A constant injection rate was used according to the instructions for use (ifu).The onyx injection was interrupted for less than 2 minutes.The injection interval was 1 minute.There was backflow of onyx of more than 1cm.The broken catheter was removed from the patient, and no medical/surgical intervention was required. the patient did not experience any health damage.The devices were prepared and flushed according to the ifu.
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Event Description
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Additional information received reported the liquid embolic agent did not get embedded in an unintended location.If the injection could be continued normally, the embolization of nydus in the avm would have been continued, but the burst caused the injection of onyx to be discontinued after that.It is a pre-treatment embolus prior to explant, and the embolus is not the final purpose.The cause of the event was not determined.
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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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Search Alerts/Recalls
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