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Model Number CATRXKIT |
Device Problems
Failure to Advance (2524); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2021 |
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 using an indigo system catrx aspiration catheter (catrx) and sheath.During the procedure, while advancing the catrx into the patient, the distal end of the catrx became kinked and would not track along the guidewire.Therefore, it was removed.The procedure was completed using a new catrx with the same sheath and guidewire.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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