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: the physical device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows a section of the touhy-borst adaptor and a section of the filter storage tube.The pusher catheter is seen in the adaptor with the pusher wire completely detached and in the storage tube.The filter can be seen inside the storage tube.Therefore, based on the photo review, failure to advance can be confirmed as the filter was seen inside the storage tube.Also, detachment was identified as the pusher wire was detached.A definitive root cause for the alleged failure to advance and the identified detachment could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 08/2026) 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.H3 other text : device not returned.
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