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Catalog Number CATRXKIT |
Device Problems
Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2023 |
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, an investigation cannot be performed.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 popliteal artery using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.During the procedure, the physician completed one pass.While retracting the catrx to perform an angiogram, the physician experienced resistance.The catrx kinked and fractured outside the patient with the remainder being in the patient.Subsequently, the remainder piece of the catrx was removed.The procedure was completed using balloon angioplasty and a stent.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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