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 inadvertently kinked the cat6 while attempting to advance it into a non-penumbra sheath; therefore, the cat6 was removed.The procedure was completed using a new cat6 and the same non-penumbra sheath.There was no report of an adverse effect to the patient.
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