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Model Number CATRXKIT |
Device Problems
Material Deformation (2976); Suction Failure (4039)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2021 |
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, prior to any passes the catrx kinked.Afterwards, when the physician initiated aspiration, he was unable to obtain good aspiration and subsequently, no blood flow was coming through the aspiration tubing (tubing) or the canister.Therefore, the catrx was removed.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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