It was reported that during an inferior vena cava filter placement procedure through right jugular vein approach, the sheath was tried to insert into the puncture site, but it was allegedly unable to be inserted and tried repeatedly to cut the skin.It was further reported that the sheath dilator was allegedly too soft and it passed through the body surface but could not pass through the vessel wall, and when the dilator was pulled back, the tip of the dilator was allegedly torn and the guidewire was hooked.Reportedly, the tip of the dilator is also turned up from the tear.The procedure was completed using another device.There was no reported patient injury.
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 05/2026).H11: section a through f ¿ the information provided 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.H3 other text : device not returned.
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