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Model Number CATRXKIT |
Device Problems
Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)
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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 11/20/2020 |
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 left anterior descending (lad) artery using an indigo system catrx aspiration catheter (catrx).During the procedure, as the physician was attempting to advance the catrx through the guide, the physician experienced resistance, and the wire exited the rapid exchange port of the catrx early.Therefore, the catrx was removed.The procedure was completed using a new catrx and the same guide.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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