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Model Number CATRXKIT |
Device Problems
Material Deformation (2976); Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2021 |
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 right coronary artery (rca) using an indigo system catrx aspiration catheter (catrx).During the procedure, while attempting to make the first pass, the physician advanced the catrx into the target vessel and noticed the catrx was not aspirating.Therefore, the physician decided to remove the catrx.However, while removing the catrx, the physician noticed the midshaft of the catrx to be kinked.The procedure was completed using a new catrx.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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