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Model Number CATRXKIT |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
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 left anterior descending (lad) artery using an indigo system catrx aspiration catheter (catrx), a 6f guide catheter, and a guidewire.During the procedure, while attempting to advance a catrx through the guide catheter to the target vessel over the guidewire through the guidewire lumen, the physician experienced resistance.Therefore, the catrx was removed.The procedure was completed using a new catrx and the same guide catheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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