Model Number S-60-040-120-P6 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/08/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was received.Investigation has not yet been completed.A follow up report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported that during preparation of the supera self-expanding stent (ses), the nosecone came off the device.There was no forced manipulation, it just easily came off.Therefore, the device was exchanged for a new supera.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was returned for analysis.The reported material separation was able to be 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during unpackaging/stylet removal and/or during preparation for use resulted in the reported tip separation/noted inner member separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|