Catalog Number C-HS-3045 |
Device Problems
Difficult to Insert (1316); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/05/2018 |
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 were no ncmr¿s for the reported lot number.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, hs iii proximal seal did not load into the delivery system properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal did not load into the delivery system properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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