Catalog Number C-HSK-3038 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/21/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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 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 a coronary artery bypass procedure using hs iii proximal seal system 3.8mm.When device was passed up to the field, the surgeon noticed that it was not loaded properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
|
|
Manufacturer Narrative
|
(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with evidence of blood on the loading device were observed.The delivery device was inside the loading device when it was returned.The seal and tension spring assembly was also inside the loading device.It was observed that the blue slide lock was engaged and the white plunger was not pressed on the delivery device.No visual defects were observed.To simulate loading of the seal, a loading procedure was performed following the ifu.The delivery tube was then pulled out of the loading device for inspection.The seal and tension spring assembly appeared to have loaded properly into the tube.The seal and the tension spring assembly were then pulled out from the delivery tube for inspection.The partially rolled up seal appeared intact with no cracks nor delamination.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.197 in., the outer diameter was measured at 0.218 in.The length of the delivery tube was measured at 2.50 inches.The measurement values recorded for the delivery tube 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 not confirmed.
|
|
Event Description
|
The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal system 3.8mm.When device was passed up to the field, the surgeon noticed that it was not loaded properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
|
|
Search Alerts/Recalls
|