Catalog Number C-HS-3045 |
Device Problem
Component Falling (1105)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance which could be considered related to the reported event recorded in the lot history 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.
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, the hs proximal seal dropped inside of the delivery device.Another product was used to complete the procedure,.No patient injury was reported.
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, the hs proximal seal dropped inside of the delivery device.Another product was used to complete the procedure,.No patient injury was reported.
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Search Alerts/Recalls
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