Catalog Number C-HS-3045 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 03/24/2017 |
Event Type
Injury
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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 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 a coronary artery bypass procedure, hs iii proximal seal 3045 seal didn¿t deploy properly and it was unable to stop bleeding.No patient injury was reported.A replacement device was used to finish out the procedure.No adverse effect to the patient was reported.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal 3045 seal didn¿t deploy properly and it was unable to stop bleeding.No patient injury was reported.A replacement deice was used to finish out the procedure.No adverse effect to the patient was reported.
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Search Alerts/Recalls
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