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 using an indigo system catrx aspiration catheter (catrx), a non-penumbra guide catheter, a guidewire, and a sheath.Initially, it was reported by the doctor that during the procedure, while advancing the catrx through the non-penumbra catheter, the distal end of the catrx broke off.However, subsequently it was reported by the staff that the doctor was able to make one pass and remove some clot.While attempting to remove the catrx to flush it before the second pass, the distal end of the catrx broke off when exiting the non-penumbra catheter, outside the patient.Therefore, the catrx was not used.The procedure was completed using a non-penumbra catheter and the same sheath.It is unknown if there was report of an adverse effect to the patient.
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