Model Number FT242T |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with product yasargil ti temp std-clipslt-cvd 6.5mm.Specifically, it was reported that the neurosurgeon left a temporary clip implanted due to the risk of aneurysm rupture.The patient is currently stable.As of the date of this report, there was no patient harm reported.Additional patient information is not available.(b)(4).Associated medwatch-reports: 9610612-2020-00293 ((b)(4)).
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Event Description
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Associated medwatch-reports: 9610612-2020-00293 (400477323 / ft222t).
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Manufacturer Narrative
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Investigation results: the devices are not available for investigation.The device history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.There is no indication for a manufacturing error or a material failure.There are no similar complaints against the same lot number."the client reports that the surgeon left a temporary clip implanted due to risk of aneurysm rupture[.]".Regarding this statement and the notice in the ifu the root cause of the problem is most probably usage related.The implanted product is not intended to remain in the body permanently.In addition a section of the ifu states that the permanent prevention of vessels by means of temporary clips is contraindicated.As the patient is stabil at the moment any changes of the clips ( e.G.Position of the clip, migration) should be monitored.There is a increased risk of bleeding compared to the use of permanent clips.We recommend to replace the clips.
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Search Alerts/Recalls
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