Catalog Number C-HSK-3038 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/27/2017 |
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 not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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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 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).The device was returned to the factory for evaluation.Signs of clinical use and blood was observed.The delivery device was returned outside the loading device.The seal and tension spring assembly remained inside the loading device.The blue slide lock was dis-engaged and the plunger was fully pressed, which is evidence of a premature deployment.The seal was taken out from 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.198 in.The outer diameter was measured at.222 in.The length of the delivery tube was measured at 2.50in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure "fitting problem" is not confirmed.The analyzed failure "premature deployment" is 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 stayed behind in the 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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