Catalog Number C-HS-3045 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Information (3190)
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Event Date 05/12/2017 |
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 preparation for a coronary artery bypass procedure, hs iii proximal seal was not loaded into the delivery system 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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Disregard the previous entry.(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.The delivery device was returned outside of the loading device.The seal and tension spring assembly remained partially inside the delivery tube.The seal and tension spring assembly failed to load in the delivery tube properly.The seal and tension spring assembly were removed from the delivery tube for observation.The seal was observed to be intact with no cracks or delamination.The slide lock was engaged.The plunger was not depressed on the delivery device.Based upon the received condition of the device, the reported complaint for ¿fitting problem¿ was confirmed (b)(4).
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal was not loaded into the delivery system properly.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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