Model Number SGC0701 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 09/03/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
This is being filed to report the leak in the steerable guide catheter (sgc).It was reported that during preparation of the sgc, the hemostatic valve lost column.Troubleshooting was performed however was unsuccessful.The device was not used.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and without a device to analyze a cause for the reported leak could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|