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 the indigo system aspiration catheter 6 (cat6) was kinked within the sealed packaging.The damage to the cat6 was found prior to use.Therefore, the cat6 was not used in the procedure.The procedure was completed using other devices.
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