|
Catalog Number CAT8XTORQ115 |
Device Problem
Material Deformation (2976)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/29/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
|
|
Event Description
|
The patient was undergoing a thrombectomy procedure in the are right superficial femoral and right popliteal arteries using an indigo system aspiration catheter 8 (cat8).During the procedure, the physician kinked the cat8.Therefore, the cat8 was removed.The procedure was completed using a new catheter.There was no report of an adverse effect to the patient.
|
|
Search Alerts/Recalls
|
|
|