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 popliteal artery using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, the physician used the peel-away introducer sheath to introduce the cat6 to the sheath.Subsequently, resistance was encountered while advancing the cat6 in the sheath and the cat6 tip became stretched.Therefore, the cat6 was removed.The sheath was then dilated and re-introduced to the patient.The procedure was completed using a new cat6 and the same sheath.There was no report of an adverse effect to the patient.
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