Model Number M00202175126P0 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/18/2014 |
Event Type
malfunction
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Event Description
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The hospital reported that a surgeon used a 26mm 15cm hemashield platinum wdv with a 25mm sorin valve.When the graft was significantly larger than the valve, he measured the internal diameter.The internal diameter of the 26 hemashield was actually 29mm.The graft was used in the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's all events are tracked and trended to determine whether or not any trends develop.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.There are no other similar complaints reported against this batch.(b)(4).
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Search Alerts/Recalls
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