Model Number 352506070E |
Device Problems
Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/02/2022 |
Event Type
malfunction
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Event Description
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Jugular approach when placing filter.Upon deploying-filter legs did not properly deploy.Piece of material stuck on filter when removed from patient/procedure.Physician placed second optionelite suprarenal with no issue.Not sure at this time of retrieval plan.
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Manufacturer Narrative
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Sample is indicated as returned.As of the date of this report, sample has not been investigated.A follow-up report will be submitted once the sample has been reviewed.
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Event Description
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Case 1: jugular approach when placing filter.Upon deploying-filter legs did not properly deploy.Piece of material stuck on filter when removed from patient/procedure.Physician placed second optionelite suprarenal with no issue.Not sure at this time of retrieval plan.
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Manufacturer Narrative
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A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.Quality engineer, manufacture engineer and complaint analyst reviewed the sample returned from the customer.Customer returned delivery catheter sheath, dilator, pusher wire and filter (filter removed from the cartridge) in the cartridge.Upon investigation, it was found that plastic was removed from the delivery catheter sheath and wrapped up the filter causing filter to not deploy and complaint was confirmed.Capa c-2020-052 will investigate root cause and corrective action of this issue.
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Event Description
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Case 1: jugular approach when placing filter.Upon deploying-filter legs did not properly deploy.Piece of material stuck on filter when removed from patient/procedure.Physician placed second optionelite suprarenal with no issue.Not sure at this time of retrieval plan.
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Search Alerts/Recalls
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