Model Number 26605 |
Device Problem
Entrapment of Device (1212)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/09/2019 |
Event Type
malfunction
|
Event Description
|
It was reported that a catheter and guidewire entrapment occurred.After a 300 es j choice guidewire crossed the lesion, a 10.0-31 carotid wallstent was advanced for treatment.However, when the stent was attempted to be released, it was noted that the guidewire stuck within the stent system and could not be released.The wallstent delivery system and the choice guidewire were removed together and the procedure was completed with another wallstent and another guidewire.There were no patient complications nor injuries reported and the patient's condition was stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: the device was returned loaded on to the customer's guidewire.During product analysis the customer's guidewire was found to be frozen inside the guidewire lumen of the returned device.A microscopic examination identified a blockage at the guidewire port of the device.For investigation purposes the investigator dissected the outer shaft of the device slightly to facilitate the removal of the customer's guidewire.A microscopic examination identified that the polymer coating of the customer's guidewire was damaged, peeling and bunched up at more than one location.It is unknown what could have caused this to happen.Although the outer shaft had been dissected slightly the investigator was able to successfully insert a new boston scientific 0.014" filterwire through this device with no resistance or issues experienced.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 fully mounted in the correct place on the device.No issues were identified with the returned device during the product analysis.
|
|
Event Description
|
It was reported that a catheter and guidewire entrapment occurred.After a 300 es j choice guidewire crossed the lesion, a 10.0-31 carotid wallstent was advanced for treatment.However, when the stent was attempted to be released, it was noted that the guidewire stuck within the stent system and could not be released.The wallstent delivery system and the choice guidewire were removed together and the procedure was completed with another wallstent and another guidewire.There were no patient complications nor injuries reported and the patient's condition was stable.
|
|
Search Alerts/Recalls
|