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 physician inadvertently kinked the indigo system aspiration catheter 8 (cat8) upon removal from the packaging.The cat8 became kinked prior to use and therefore, was not used for the procedure.The procedure was completed using a new cat8.
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