Model Number FRED4508-PMA |
Device Problem
Activation Failure (3270)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/31/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.
|
|
Event Description
|
It was reported that upon deployment of the fred in the internal carotid artery, the device was partially expanded.The stent was completely expanded with additional guide wire manipulations.There was no reported patient injury.The patient is currently reported to be doing well.
|
|
Search Alerts/Recalls
|