Model Number HST III SYSTEM (3.8MM) |
Device Problem
Activation Problem (4042)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.Device discarded.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) did not deploy 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).A lot history record review was completed for lots 25150836, 25151572 and 25148140 the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) did not deploy properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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