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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During preparation for a thrombectomy procedure using an indigo system aspiration catheter 6 (cat6), the physician accidentally dropped the cat6 on the floor.The cat6 was dropped prior to use and, therefore, was not used in the procedure.The procedure was completed using an indigo system aspiration catheter 5 (cat5) and an indigo system separator 5 (sep5).There was no report of an adverse effect to the patient.
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