Catalog Number C-HSK-3038 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/02/2017 |
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 was no nonconformance recorded in the lot history.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system deployed while being removed from loading device.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).The device was returned to the factory for evaluation.Signs of clinical use and slight evidence of blood on the loading device were observed.The delivery device was returned inside the loading device.The delivery device was removed from the loading device.The seal and tension spring assembly remained inside the loading device.The blue slide locks were engaged and the plunger was not depressed on the delivery device.The seal and tension spring assembly were removed from the loading device, and was observed to be intact with no cracks or delamination.The following measurement were taken; the inner delivery tube diameter was measured at.197 in.The outer diameter was measured at.217 in.The length of the delivery tube was measured at 2.53 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for "premature deployment" was not confirmed, but the analyzed failure "fitting problem" was confirmed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system deployed while being removed from loading device.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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