|
Model Number CATRXKIT |
Device Problems
Break (1069); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/02/2021 |
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 using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guidewire.During the procedure, while advancing the catrx over a guidewire and into the sheath, the physician kinked and broke the catrx at the midshaft.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
|
|
|