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Model Number CATRXKIT |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2021 |
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.
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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).During the procedure, the technician noticed blood leaking out near the hub of the catrx while performing aspiration.Therefore, the catrx was removed.The procedure was completed using a non-penumbra device.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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