Model Number 1011344-40 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/24/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
|
|
Event Description
|
It was reported that the acculink stent was to be used to treat the distal internal carotid artery.However, during preparation and before use of the device, it was noted that the nose cone was not fixed to the catheter.The device was not used in the patient.There was no patient involvement.The decision was made to treat the patient with a carotid endarterectomy procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was returned for analysis.The reported tip material separation was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during preparation for use and/or during advancement onto the guide wire inadvertent mishandling resulted in the reported tip material separation/noted inner member separation.Inadvertent mishandling during packing for return analysis likely resulted in the noted stent deployment.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|