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 observed that the tip of an indigo system aspiration catheter 8 (cat8) was flattened upon opening the package.The damage to the cat8 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new cat8.
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