It was reported that during vena cava filter placement via the right internal jugular vein, the guidewire allegedly difficult to advance.It was further reported the tip of the sheath allegedly migrated and the filter was expanded in the iliolumbar vein during insertion.Reportedly, the filter was removed by a snare.The procedure was completed by using same device.There was no reported patient injury.
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It was reported that during vena cava filter placement via the right internal jugular vein, the guidewire allegedly difficult to advance.It was further reported the tip of the sheath allegedly migrated and the filter was expanded in the iliolumbar vein during insertion.Reportedly, the filter was removed by a snare.The procedure was completed by using same 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 the denali filter system that are cleared in the us.The pro code and 510 k number for the denali filter 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 jugular delivery system kit was returned for evaluation.During visual evaluation, there is no visual anomaly noted to the dilator.Therefore, the investigation is remains inconclusive for the difficult to advance and activation, positioning or separation problem issue as there is no clear evidence.A definitive root cause for the alleged difficult to advance, and activation, positioning or separation problem 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: 04/2025),.
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