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Model Number 105-5056 |
Device Problem
Break (1069)
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Patient Problems
Death (1802); Headache (1880); Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)
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Event Date 08/01/2018 |
Event Type
Death
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Manufacturer Narrative
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The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.Attempts have been made to gather additional information, however, our attempts have been unsuccessful.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.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 report that during an arteriovenous malformation (avm), the marathon catheter was alleged to have broken in the proximal section.The patient was reported to not to have symptoms related to this device malfunction.However, post the intervention the patient did experience a headache and did expire sometime afterwards.The patient was being treated with onyx for an arteriovenous malformation.The onyx was being injected for approximately 4-5 minutes into the treating vessel.Upon retrieving the marathon microcatheter by creating tension to the catheter tip (multiple times).The catheter separated in the proximal area releasing some onyx into the parent artery.A solitaire stent retriever was then used to plasty the onyx to the parent artery wall.It was also reported that an attempt was made to retrieve the broken catheter, with the solitaire device with no success.The patient was sent to pacu intact, an hour later, the patient complained of a headache and began to decline.The patient ultimately did pass away.
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Manufacturer Narrative
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Corrected: patient code.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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