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Model Number PED-375-35 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/06/2020 |
Event Type
Injury
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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 regarding a pipeline pushwire broke during attempt to withdraw.The patient was being treated for an unruptured saccular aneurysm.The aneurysm max diameter was 11mm and the neck diameter was 9mm.Vessel tortuosity was normal.It was reported that after the pipeline was successfully implanted, the catheter was made to go superior to withdraw the guidewire.However, the catheter was unable to move upward and had to be adjusted.While withdrawing the catheter, the marking point at the proximal side of the guidewire broke.The proximal marking point and the guidewire then could not be withdrawn and remained in the patient's body.There were no patient symptoms related to the event.
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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 that when the catheter was advanced and the guidewire was retrieved, the product couldn't go high smoothly due to vascular problems.In the process of withdrawing, the guidewire broke, and the distal part of the guideware was found to have resistance.The broken segment of the pushwire was not removed from the patient.Postoperative medication was used to avoid ischemic events.No other measures were taken to remove the fractured portion from the body, and the patient was asymptomatic.
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Search Alerts/Recalls
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