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, the indigo system aspiration catheter 8 (cat8) was stretched at the tip upon removal from the packaging.The damage to the cat8 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using another cat8.
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