H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the denali filter products that are cleared in the us.The pro code and 510k number for the denali filter products is identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one denali femoral delivery system was returned for evaluation.During visual evaluation, storage tube and touhy was observed to be loaded onto pusher catheter with pusher wire appearing to be detached.Therefore, the investigation is confirmed for the reported failure to advance as detached portion of the pusher wire noted to be stuck in the filter and the investigation is confirmed for the identified detachment issues as pusher wire was noted to be detached.A definitive root cause for the reported failure to advance and the identified detachment issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2025).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|