After further review of additional information received the sections have been updated accordingly.As reported, foreign material was confirmed to be inside a sterilized pouch of a tempo.There is no reported patient injury.Additional procedural details were requested but are unknown.The device was not returned for analysis.A device history record (dhr) review of lot 17657037 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box foreign material - in sterile package¿ could not be confirmed as the device was not returned for analysis and/or pictures of the material was not provided.The exact cause of the reported foreign material reported could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue as it is unknown what kind of foreign material the customer may have noticed.As cautioned in the instructions for use, which is not intended as a mitigation, ¿do not use if package is open or damaged.Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.Prior to use, flush the guiding catheter lumen with a heparinized saline solution.¿ neither the dhr nor the information 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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