Medtronic received information that during an off-pump coronary artery bypass (opcab) case, the surgeon noticed the end of the octopus tissue stabilizer where the ball head is located on the headlink, was rubbing on the heart and caused a 'scratch'.The customer stated that the scratch was not extensive or deep.The customer was concerned that there would be residual bleeding.The octopus was used to complete the procedure.No additional adverse patient effects occurred.The customer stated that nothing atypical was noted with the octopus that could have caused the scratch.There was no damage noted to any of the product packaging.
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H3.The customer discarded the device.Investigation conclusion: medtronic cannot confirm or deny the complaint of the device malfunction causing a scratched heart as no product has been returned.An analysis of this occurrence could not be performed without the returned product.The cause of this complaint could not be determined, but it suspected to be caused by incorrect positioning of the device.The device history record could not be reviewed as no lot number was provided.A review of complaints received from june 2016 through july 2019 for this model number found no similar occurrences.Although there was a scratch on the heart, there were no permanent adverse patient effects as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends.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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Medtronic received information that during an off-pump coronary artery bypass (opcab) case, the surgeon noticed the end of the octopus evo tissue stabilizer where the ball head is located on the headlink, was rubbing on the heart and caused a 'scratch'.The customer stated that the scratch not extensive or deep but significant enough for them to have a concern.The customer was concerned that there might be residual bleeding.See attached diagram.The octopus was used to complete the procedure.No additional adverse patient effects occurred.The customer stated that nothing atypical noted with the octopus that could have caused the scratch.There was no damage noted to any of the product packaging.
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