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.Additional 510(k)#s that also apply to this complaint: k160533, k161523.
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The patient was undergoing a thrombectomy procedure in the vena cava using an indigo system catd aspiration catheter (catd).During the procedure, the catd was inadvertently bent while being advanced into a non-penumbra sheath.Therefore, the catd was removed, and the procedure was completed using a new catd and the same sheath.There was no report of an adverse effect to the patient.
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