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.The hospital disposed of the device.
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The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician advanced the cat6 through a non-penumbra sheath which was reported to be incompatible.Consequently, the cat6 became stuck and collapsed during removal.The procedure was successfully completed using another catheter.There was no report of an adverse effect to the patient.
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