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, the indigo system aspiration tubing (aspiration tubing) was dropped on the floor upon removal from the packaging.The aspiration tubing was dropped prior to use and therefore, was not used in the procedure.The procedure was completed using a new aspiration tubing.
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