Additional 510(k) numbers that also apply to this complaint: k160533; k161523.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 that an indigo system aspiration catheter d (catd) was kinked upon removal from the packaging.The damage to the catd was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using another catd.
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