Catalog Number C-HSK-3043 |
Device Problems
Failure to Advance (2524); Activation Problem (4042)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/15/2018 |
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 were no ncmr¿s for the reported lot number.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 using hs iii proximal seal system 4.3mm.They found that the protective umbrella of the proximal heartstring could not be pushed to the lesion site normally.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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Internal complaint # trackwise # (b)(4).Autonumber # (b)(4).Only the seal and heartstring was returned to the factory for evaluation.A visual inspection was conducted.Only the heartstring and tension spring assembly was returned for evaluation.Signs of clinical use and no evidence of blood was observed.The seal and tension spring was observed to be intact, with no visual defects.The seal was observed to be intact, no cracks or delamination was observed on the seal.No measurements of the delivery tube were taken as the delivery device was not returned for evaluation.Based on the return condition of the incomplete device, the reported failure "activation problem" was not confirmed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal system 4.3mm.They found that the protective umbrella of the proximal heartstring could not be pushed to the lesion site normally.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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