Catalog Number C-HSK-3038 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/16/2018 |
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, hs iii proximal seal system 3.8mm was loaded.When hospital removed the delivery device from the loading device, the heartstring got stuck in the loader and did not come out in the delivery device.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 device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned outside the loading device.The seal and tension spring was not returned for evaluation.The slide lock engaged and the white plunger was not depressed on the delivery device.There were no visual defects observed.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at.196 inches, the outer diameter was measured at.220 inches.The length of the delivery tube was measured at 2.51inches.The values recorded were within the tolerance specifications.Based on the return condition of the device, and the non- return of the seal and tension spring, the reported failure "fitting problem" was not confirmed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm was loaded.When hospital removed the delivery device from the loading device, the heartstring got stuck in the loader and did not come out in the delivery device.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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