|
Model Number CATRXKIT |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/13/2021 |
Event Type
Injury
|
Event Description
|
The patient was undergoing a thrombectomy procedure in the anterior tibial and peroneal artery using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.During the procedure, the physician used the catrx to aspirate clot out from the target location.Subsequently, while retracting the catrx from the patient, the catrx broke into two pieces in the superficial femoral artery (sfa).Therefore, the physician advanced a non-penumbra balloon catheter to capture and retract the broken pieces of the catrx back into the sheath from sfa.The sheath and balloon were then removed together containing the broken pieces of the catrx.The procedure had ended at this point.There was no report of an adverse effect to the patient.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|