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.
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During preparation for a thrombectomy procedure, the hospital staff noticed that the distal tip of an indigo system aspiration catheter (cat8) was kinked upon opening of the package.The damaged cat8 was found prior to use, and, therefore, was not used in the procedure.The procedure was completed using a new cat8.
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