Catalog Number C-HSK-3043 |
Device Problems
Fitting Problem (2183); Activation, Positioning or Separation Problem (2906); 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 12/17/2018 |
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 an endoscopic vein harvesting procedure using hs iii proximal seal system 4.3mm.They found that the protective umbrella of the proximal heartstring could not be normally inserted into the delivery sheath.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).Only the heartstring and the tension spring assembly was returned to the factory for evaluation.A visual inspection was conducted.Slight blood was observed on the seal.The tension spring assembly was attached to the seal and there were no visual defects.The seal was observed to be intact, with slight blood on the seal.No cracks or delamination was observed on the seal.Based on the incomplete device return, and the evaluation, the reported failure "fitting problem" was not confirmed.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using hs iii proximal seal system 4.3mm.They found that the protective umbrella of the proximal heartstring could not be normally inserted into the delivery sheath.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using hs iii proximal seal system 4.3mm.They found that the protective umbrella of the proximal heartstring could not be normally inserted into the delivery sheath.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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