Catalog Number C-HS-3045 |
Device Problems
Crack (1135); Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/12/2018 |
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 cracked and was unable to be loaded into the tube properly when delivery system was pushed into the loading device and pulled out.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 cracked and was unable to be loaded into the tube properly when delivery system was pushed into the loading device and pulled out.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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