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 hospital technologist inadvertently kinked an indigo system aspiration catheter 8 (cat8) while removing it from the packaging on the back table.The kinking of the cat8 occurred prior to use and therefore, the cat8 was not used in the procedure.The procedure was completed using a new cat8.
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