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Catalog Number CATRXKIT |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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.H3 other text : placeholder.
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Event Description
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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 (.014).During the procedure, the non-penumbra sheath was advanced to the aortic bifurcation.The physician then advanced the catrx through the sheath to the target location and completed a few passes.While retracting the catrx after completion of the last pass, the midshaft of the catrx fractured.Therefore, the catrx was removed from the patient.It was noted that the guidewire may have been wrapped around the catrx.The procedure ended at this point.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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