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 device was discarded by the hospital.
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During preparation for a thrombectomy procedure, the scrub technologist inadvertently knocked over the newly opened indigo system cat6 aspiration catheter (cat6).The cat6 was knocked over prior to its use and therefore, was not used for the procedure.The procedure was completed using a new cat6.
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