|
Model Number CATRXKIT |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/02/2020 |
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 manufacturing records for this lot were reviewed, and did not reveal any outstanding discrepancies, design, or quality concerns.
|
|
Event Description
|
The patient was undergoing a thrombectomy procedure in the tibial artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guidewire.During the procedure, the physician encountered resistance while advancing the catrx over the guidewire into the sheath.The physician continued to advance the catrx, and the tip became smashed.Therefore, the catrx was removed.The procedure was completed using a new catrx and the same sheath.There was no report of an adverse effect to the patient.
|
|
Search Alerts/Recalls
|
|
|