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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The patient was undergoing a thrombectomy procedure in the circumflex artery using an indigo system catrx aspiration catheter (catrx).During the procedure, while attempting to advance the catrx over a guidewire, the catrx lumen was punctured.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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