|
Model Number 84590 |
Device Problems
Mechanical Problem (1384); Obstruction of Flow (2423); Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/17/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the image were not clear under fluoroscopy.The target lesion was located in the hepatic artery.A direxion transend-14 system was selected for use.During the procedure, the microcatheter with poor liquidity was advance into the microvasculature with the help of the rh catheter.The 2ml contrast was injected with difficulty.Even with high-pressure syringe to inject the contrast, the image was not clear, and it was noted that the catheter could hardly be seen.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
|
|
Manufacturer Narrative
|
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was microscopically analyzed for any damage.No shaft damage was noticed.The device was x-rayed and showed no obstruction.The tip was x-rayed, and the marker band was noticeable on the device.Fluid was injected through the device and showed the lumen was patent, and no obstruction was confirmed.A.014 test guidewire was inserted into the devices lumen to confirm the lumen patency.No obstructions were noticed.A torque test was completed by applying a piece of tape to the tip of the device.The shaft was rotated to see what response the tip may have.The tip turned 1 for 1 during a 360 degree turn of the catheter shaft.No issues on the torque were noticed.Inspection of the remainder of the device revealed no damage or irregularities.The device was not confirmed for obstruction or not identifying the tip under x-ray.
|
|
Event Description
|
It was reported that the image were not clear under fluoroscopy.The target lesion was located in the hepatic artery.A direxion transend-14 system was selected for use.During the procedure, the microcatheter with poor liquidity was advance into the microvasculature with the help of the rh catheter.The 2ml contrast was injected with difficulty.Even with high-pressure syringe to inject the contrast, the image was not clear, and it was noted that the catheter could hardly be seen.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
|
|
Search Alerts/Recalls
|
|
|