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 new scrub technologist inadvertently bent the indigo system aspiration catheter 6 (cat6) while removing it from the packaging.The cat6 became damaged prior to use and therefore, was not used for the procedure.The procedure was completed using a new cat6.
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