Medtronic received a report that dilation was observed in the rebar catheter.It was reported that the healthcare provider (hcp) positioned the microcatheter, but when injecting contrast medium, a dilation was observed in the proximal mark in the fluoroscopy.As a result, the microcatheter was changed out.No patient symptoms or further complications were reported as a result of this event.
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The rebar-18 micro catheter was returned.The rebar-18 micro catheter was measured to be within specification.No issues were found with the rebar-18 micro catheter hub or distal tip.The catheter body was found to be kinked at a few locations.The rebar micro catheter was flushed, and water exit from only the distal tip without issue.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿catheter leak¿ was unable to be confirmed as water exited only from distal tip without issue.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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