MICRO THERAPEUTICS, INC. DBA EV3 HYPERFORM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
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Model Number 104-4770 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2021 |
Event Type
malfunction
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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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Event Description
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Medtronic received information reporting that a hyperform balloon which ruptured during testing.The hyperform was replaced.The patient was being treated for left carotid artery (l-ica) occlusion.It was noted that patient was safe and the procedure was completed successfully.
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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 clarified that the balloon burst during the procedure.The physician had tested the balloon prior to use, and it had performed as intended.The guidewire tip was advanced 2cm out of the catheter tip during inflation.The physician had shaped the guidewire, and the balloon rupture occurred in the middle of the device.A 70% contrast ratio was used.The balloon was inflated and deflated 3 times, and the injection rate was slow.A 1cc lock syringe had been used.The patient's vessel tortuosity was normal.
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Manufacturer Narrative
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H3.Product analysis: the hyperform occlusion balloon catheter and guidewire were returned for analysis.The hyperform guidewire was found protruding from within the catheter hub for ~23.6cm and from the distal tip for ~18.0cm.No bends or kinks were found with the hyperform catheter body.The hyperform guidewire distal tip was found bent.The guidewire was positioned with an undamaged section at the balloon tip.An attempt was made to inflate the balloon; however, the balloon could not maintain inflation as it was found to be leaking distal to the distal marker band.Upon microscopic examination, a defect (tear) in the balloon chronoprene tubing was found at the location of the leak.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿rupture¿ could not be confirmed as the balloon was not found to be ruptured.However, the device evaluation showed the balloon could not maintain inflation due to the defect (tear) in the chronoprene tubing.The defect observed is consistent with mechanical or navigation related damage rather than those caused by over-inflation (rupture).No issues were reported preparing the balloon prior to use and the balloon was inflated and deflated 3 times; therefore, the damage likely occurred during the procedure.It is possible the use of a 70% contrast ratio contributed to the event.H6.Coding was updated based on device analysis findings.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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