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 medical procedure using an indigo system aspiration catheter 6 (cat6), the hospital technician removed the cat6 from the packaging and noticed the distal tip was ¿flattened¿.The technician then attempted to open the distal tip of the cat6 with the dilator from a 6 fr non-penumbra sheath on the back table; however, was unsuccessful.The damage to the cat6 was found prior to use.Therefore, the cat6 was not used in the procedure.The procedure was completed using a new cat6.
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