Catalog Number C-HSK-3038 |
Device Problems
Sticking (1597); Device Operates Differently Than Expected (2913)
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Patient Problem
No Information (3190)
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Event Date 01/18/2017 |
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.
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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 3.8 mm did not load correctly into delivery device, appeared to get stuck in delivery 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 evidence of blood were observed.Blood was observed on the loading device.The delivery device was returned outside the loading device.The seal and tension spring assembly remained inside the loading device.The slide lock was engaged.The plunger was not depressed on the delivery device.Seal was removed outside the loading device for inspection.No crack/delamination of seal was observed.The following measurements were taken; the inner delivery tube diameter was measured at.197 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.49 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for failure to load was confirmed and failure to deploy was not 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 3.8mm did not load correctly into delivery device, appeared to get stuck in delivery 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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