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Model Number 105-5091-150 |
Device Problems
Break (1069); Collapse (1099)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2022 |
Event Type
malfunction
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Event Description
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Medtronic received a report that the distal end of the echelon microcatheter was broken/ ruptured and crushed prior to use with the patient.The catheter had been molded by a heat gun at 100 degrees for 30 seconds.There was no other damage to the catheter. the catheter was replaced, and the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for coil embolization of a right posterior communicating artery aneurysm.The patient's vessel tortuosity was normal.The access vessel was the femoral artery, which was 6.2mm in diameter.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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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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Additional information received reported during the operation, the echelon microcatheter was molded by a heat gun at 100 degrees for 30 seconds, and then the distal end of the microcatheter was ruptured at the mark, and the microcatheter could not be used.It may be damaged before opening.No issues resulted from the damage that was found.
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Manufacturer Narrative
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H3: an echelon-10 micro catheter was returned for analysis.The echelon-10 total length was measured to be ~155.6cm.The echelon-10 useable length was measured to be ~147.5cm.Upon visual examination, no issues were found with the echelon-10 hub.No bends or kinks were found with the echelon-10 catheter body.The distal tip was found to be separated but still but retained by tubing material at proximal end of distal marker band.The distal tip appeared to be shaped.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed.Per the echelon ifu (instructions for use), the user is to, ¿use only a steam source to shape the catheter tip.Do not use other heat sources.¿ in this event, user error likely contributed to the event as it was reported the echelon-10 micro catheter tip was shaped by heat gun.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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