Model Number 44021 |
Device Problem
Entrapment of Device (1212)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/26/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that device entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.The opti cross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the device was stuck with the guidewire.The device was removed from the patient's body along with the guidewire.The procedure was completed with another of the same device, and no patient complications were reported due to this event.
|
|
Manufacturer Narrative
|
Device analysis by mfr: the device was returned for analysis.Visual inspection revealed the imaging window was observed twisted and kinked.Microscopic inspection revealed the guidewire exit port was deformed, but the tip was in good condition.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.
|
|
Event Description
|
It was reported that device entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.The opti cross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the device was stuck with the guidewire.The device was removed from the patient's body along with the guidewire.The procedure was completed with another of the same device, and no patient complications were reported due to this event.
|
|
Search Alerts/Recalls
|