Model Number HST III SYSTEM (3.8MM) |
Device Problem
Failure to Unfold or Unwrap (1669)
|
Patient Problem
Death (1802)
|
Event Date 10/12/2020 |
Event Type
Death
|
Manufacturer Narrative
|
(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
|
|
Event Description
|
The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).Customer reports patient death following cabg/avr procedure.Customer states that they utilized device and that the delivery of the seal failed.Stated that patient had chronic afib, vtac and needed right heart support.
|
|
Event Description
|
The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).Customer reports patient death following cabg / avr procedure.Customer states that they utilized device and that the delivery of the seal failed to unfold.Stated that patient had chronic afib, vtac and needed right heart support.Device did not attribute to the death of the patient.
|
|
Manufacturer Narrative
|
Trackwise#: (b)(4).The lot#: 25149986 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
|
|
Search Alerts/Recalls
|