Model Number 26605 |
Device Problems
Entrapment of Device (1212); Difficult to Advance (2920)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/25/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that catheter entrapment occurred.The target lesion was located in the right internal carotid artery.After a filterwire reached the targeted position, a 10.0-31 carotid monorail stent was unpacked, primed and flushed.When the physician advanced the stent into the guiding catheter through the filterwire from the monorail port of the stent, a large resistance was encountered and could not continue to advance.The physician withdrew the stent and filterwire together from the patient at a fully reconstrained state and found the stent become stuck with the filterwire out of the patient.The stent was removed from the filterwire by simply pulling it out.The procedure was completed with a different device.There were no complications reported and the patient is stable.
|
|
Event Description
|
It was reported that catheter entrapment occurred.The target lesion was located in the right internal carotid artery.After a filterwire reached the targeted position, a 10.0-31 carotid monorail stent was unpacked, primed and flushed.When the physician advanced the stent into the guiding catheter through the filterwire from the monorail port of the stent, a large resistance was encountered and could not continue to advance.The physician withdrew the stent and filterwire together from the patient at a fully reconstrained state and found the stent become stuck with the filterwire out of the patient.The stent was removed from the filterwire by simply pulling it out.The procedure was completed with a different device.There were no complications reported and the patient is stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: carotid wallstent monorail 10.0-31 was received for analysis.This carotid device is recommended for use with a 0.014 guidewire as per carotid wallstent instructions for use (ifu).During the product analysis a boston scientific filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent in the correct position on the device.No issues were noted with the stent that could potentially have contributed to the complaint incident.
|
|
Search Alerts/Recalls
|