|
Model Number 2213-01 |
Device Problems
Difficult to Flush (1251); Material Rupture (1546)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/10/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device eval by mfr: the returned product consisted of a trueselect 130cm microcatheter.The device was visually and microscopically inspected for any damage or irregularities.The device showed multiple bends and kinks along the shaft.The microscopic inspection did show a hole in the microcatheter shaft located approximately 120cm from the hub.The internal area of the hole did show metal braid damage.A.014 test guidewire was inserted into the device and the wire transcended through the device with a slight restriction due to the shaft damage.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.The device was confirmed for bends, kinks, and a hole in the shaft.
|
|
Event Description
|
It was reported that the catheter shaft ruptured.A truselect infusion catheter was selected for use to treat hepatocellular carcinoma (hcc) using y90.Prior to infusing y90, a contrast run was performed.The physician observed that the contrast appeared more proximal than expected.The physician then opted to embolize a distal vessel with gelfoam prior to delivering the y90 dose.However, the gelfoam could not be flushed through the catheter.The catheter was removed from the patient and flushed with saline.A small hole at the distal end of the catheter was observed.Saline was shooting out of it.A new device, same model, was used to complete the procedure.There were no patient complications.
|
|
Search Alerts/Recalls
|
|
|