H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali jugular system that are cleared in the us.The pro code and 510 k number for the denali jugular system are 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 filter kit was returned for evaluation.Following components were received: dilator, pusher catheter, introducer sheath, filter storage tube, touhy-borst adapter and filter.Filter was noted to be extending out of the storage tube with two of the legs crossed and damaged.No skiving or bowing noticed to the storage tube, no damage to the introducer sheath or dilator.Based on the findings, the investigation is confirmed for the reported failure to advance issue as the filter was noted to be extending out of the storage tube.However, the investigation is inconclusive for the reported activation failure including expansion failure as the reported event cannot be reconfirmed.A definitive root cause for the reported failure to advance and activation failure including expansion failure issues 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: 02/2024).H11:section a through f - the information provided by bd represents all of 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.
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