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Model Number CATRXKIT |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2021 |
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.This report is associated with mfr report number: 3005168196-2021-01519.
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Event Description
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The patient was undergoing a thrombectomy procedure in the right coronary artery (rca) using indigo system catrx aspiration catheters (catrxs) and a wire.During the procedure, a wire could not thread through the guidewire lumens of two catrxs.Therefore, the catrxs were removed.The procedure was completed using a new catrx and the same wire.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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