Model Number 00884450386521 |
Device Problems
Fracture (1260); Material Fragmentation (1261)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 10/23/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
|
|
Event Description
|
The account alleges that during the implant of the hero device, upon removing the peel-away sheath the hub detached and the sheath was left in the body and moved down the ivc.The surgeon and the ir physician were able to retrieve the sheath from the ivc.No patient injury to report.
|
|
Manufacturer Narrative
|
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
|
|
Search Alerts/Recalls
|