Catalog Number C-HSK-3043 |
Device Problems
Difficult to Insert (1316); Fitting Problem (2183)
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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 12/06/2018 |
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 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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Internal complaint # trackwise # (b)(4).Autonumber # (b)(4).The hsk iii device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.The load device and the delivery device was not confirmed.The seal was returned attached to the tension spring assembly.No signs of cracks/delamination.There were no observed failures.Based on the condition of the device as returned, we were unable to confirm the reported failure mode ¿fitting problem¿.
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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 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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