Model Number HS III PROXIMAL SEAL |
Device Problems
Fitting Problem (2183); Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id #(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.Device discarded.
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Event Description
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The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal, when the delivery device was pulled out from the main body of the delivery system according to the normal procedure, the proximal seal was missing.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).Device code corrected to fitting problem.
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Event Description
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The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal, when the delivery device was pulled out from the main body of the delivery system according to the normal procedure, the proximal seal was missing.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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