Catalog Number C-HSK-3038 |
Device Problem
Failure to Fold (1255)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/21/2017 |
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, hs iii proximal seal system 3.8 mm failed to load due to seal not folding properly.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.Signs of clinical use with evidence of blood were observed.The delivery device was returned inside the loading device.Traces of blood were observed on the loading device.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The seal and tension spring assembly remained inside the loading device.It was observed that the seal was visible through the window of the loading device and appeared unraveled.The delivery device was removed from the loading device.The tension spring assembly with the seal was removed from the delivery device for inspection.Microscopic inspection showed the seal to be partially unraveled.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.197 inches., the outer diameter was measured at 0.228 inches.The length of the delivery tube was measured at 2.503 inches.The values recorded were within the tolerance specifications.Based upon the received condition of the device, and the results of the evaluation, the reported failure mode "fitting problem" was confirmed.The analyzed failure mode "unraveled seal" was also 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 3.8 mm failed to load due to seal not folding properly.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: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Signs of clinical use with evidence of blood were observed.The delivery device was returned inside the loading device.Traces of blood were observed on the loading device.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The seal and tension spring assembly remained inside the loading device.It was observed that the seal was visible through the window of the loading device and appeared unraveled.The delivery device was removed from the loading device.The tension spring assembly with the seal was removed from the delivery device for inspection.Microscopic inspection showed the seal to be partially unraveled.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.197 inches., the outer diameter was measured at 0.228 inches (b)(4).The length of the delivery tube was measured at 2.503 inches (b)(4).The values recorded were within the tolerance specifications.Based upon the received condition of the device, the photos received from the complainant, and the results of the evaluation, the reported failure mode "fitting problem" was confirmed.The analyzed failure mode "unraveled seal" was also confirmed.
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Search Alerts/Recalls
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