A review of the device history records and inspection records yielded no similar concerns.A review of the complaints database was conducted, and over the previous six months, no similar complaints were found related to this part number or lot number.One unit of the same lot number was taken from product retains.The lumen of the filter was found open.The curved pusher wire was used to deploy the filter from both the femoral and jugular directions.No delamination of the sheath was found, and no additional issues were noted.No product is available for return.Based on the sample not being available for evaluation, the device documentation showing no issues, and the retain sample functioning properly, the complaint could not be confirmed.Therefore, a definitive root cause could not be determined and no corrective actions will be taken.
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A sample was returned for evaluation.Only a thin, clear filament was returned for evaluation.All the components of the kit (including the filter or sheath) were not returned.Based on visual inspection and other deployment testing results, this appears to be the inner lining of the sheath.However, a definitive cause for the delamination of the inner lining of the sheath could not be determined especially since the sheath and filter were not returned.A possible cause for the delamination of the sheath includes the filter having become offset in the sheath, engaging the sheath wall.
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