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: 3005168196-2016-01660.The hospital disposed of the device.
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The patient was undergoing a thrombectomy procedure using indigo system aspiration catheter 6 (cat6) devices.During the procedure, while attempting to insert a cat6 into a non-penumbra sheath, the physician encountered resistance after the cat6 advanced pass the sheath¿s valve and subsequently, the cat6 became kinked.Therefore, the cat6 did not enter the sheath and was removed.The physician then attempted to insert a new cat6 into the same non-penumbra sheath.However, resistance was encountered again after the cat6 advanced pass the sheath's valve and subsequently, the cat6 became kinked.Therefore, the cat6 did not enter the sheath and was removed.It should be noted that the valve was too tight.The procedure was then completed using a new indigo system cat5 aspiration catheter (cat5).There was no report of an adverse effect to the patient.
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