Catalog Number C-HSK-3038 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Information (3190)
|
Event Date 06/08/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal did not stay in the delivery portion, it stayed behind in the plastic tube.The hospital did not report any patient effects.
|
|
Manufacturer Narrative
|
(b)(4).Internal complaint number: (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.The delivery device was returned outside the loading device.The seal and tension spring assembly remained inside the loading device.The slide lock was engaged.The plunger was not depressed on the delivery device.The seal was taken out from the loading device for inspection.No crack/delamination of seal was observed.The following measurements were taken; the inner delivery tube diameter was measured at.198 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.50 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for "failure to load" was confirmed.
|
|
Event Description
|
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal did not stay in the delivery portion, it stayed behind in the plastic tube.The hospital did not report any patient effects.
|
|
Search Alerts/Recalls
|