Catalog Number C-HSK-3038 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/31/2018 |
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 was no nonconformance recorded in the lot history.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, after loading the hs iii proximal seal system 3.8mm seal and when trying to pull out of the tube, it stayed inside the tube loader.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 a coronary artery bypass procedure, after loading the hs iii proximal seal system 3.8mm seal and when trying to pull out of the tube, it stayed inside the tube loader.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 number trackwise # (b)(4).Autonumber # (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 were observed.The delivery device was returned inside the loading device.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The tension and spring assembly remained inside the loading device when the delivery tube was removed.The tension spring assembly and the seal were removed from the loading device.A microscopic inspection was conducted.The seal was observed to have a crack on the outer coil.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at.197 inches, the outer diameter was measured at.221 inches.The length of the delivery tube was measured at 2.51 inches.The values recorded were within the tolerance specifications.Based on the return condition of the device and the results of the investigation, the reported complaint "fitting problem" was confirmed as well as the analyzed failure "cracked seal".
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Search Alerts/Recalls
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