Catalog Number C-HSK-3043 |
Device Problems
Physical Resistance/Sticking (4012); 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 11/27/2018 |
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 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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(b)(4).The heartstring seal and tension spring assembly was returned to the factory for evaluation.Signs of clinical use was observed.There was no evidence of blood detected.There were cracks observed on the outer diameter of the seal.Based on the return condition of the incomplete device, the reported failure "activation problem" was not confirmed, however the analyzed failure "crack" is 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 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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