A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.A file with one picture was received for picture analysis related to complaint case-(b)(4).Per picture analysis, an optease retr filter 55 cannula unit was observed perforated by a filter barb, from the inside to the outside of the cannula.No other anomalies were observed.It is unknown if the device will be returned for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
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During implantation of a 55cm optease retrievable vena cava filter, the operator found that the barb of the optease was inserted into the side wall of the release sheath which made impossible to continue pushing.Therefore, the operator stopped the release of the filter.There was no reported patient injury.The user was trained with the device.The device will be returned for evaluation.Device image is available for review.
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Complaint conclusion: during implantation of a 55cm optease retrievable vena cava filter, the operator found that the barb of the optease was inserted into the side wall of the release sheath which made it impossible to continue pushing.Therefore, the operator stopped the release of the filter.The user was trained with the device.Device image is available for review.There was no reported injury.The device was not returned for analysis.A single photograph was provided for review.Per visual analysis of the photo, an optease retrievable filter 55 cannula unit was observed perforated by a filter barb, from the inside to the outside of the cannula.No other anomalies were observed.A product history record (phr) review of lot 17984910 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter-impeded ¿ perforated sheath¿ was confirmed by photo analysis.However, the exact cause of the reported event could not be conclusively determined by photo analysis and the limited information available.Procedural factors, such as operator technique or vessel characteristics, although unknown, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ additionally, users are clinically trained to inspect the device prior to and during use for any damages.If any damage is noticed, the ifu instructs users to replace the damaged device with a new one.Neither the phr nor the photo analysis available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
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