An optease vena cava filter was attempted to be inserted but the distal end marker of its sheath was frayed and turned outwards.It was replaced with a new product to continue the procedure.There was no patient injury and the device will be returned for analysis.A non-sterile optease retrievable filter cannula sheath introducer (csi) and a vessel dilator were received for analysis inside a plastic bag.Per visual analysis, the vessel dilator was received fully inserted into the cannula sheath.The cannula sheath introducer was received with frayed/ split/ torn damaged on the tip of the unit.The original packaging was not returned for analysis; therefore making it unable to determine if the observed damage condition was due to improper packaging.Dried blood residues were also observed on the tip of the cannula sheath.No other anomalies were found.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.The event reported by the customer as ¿brite tip (csi/filters)- frayed/split/torn¿ was confirmed.A frayed/split/torn condition was found on the cannula sheath.However, the exact cause of the condition found could not be conclusively determined during the analysis.Analysis results and phr review results do not suggest that this damage is related to the manufacturing process.Procedural factors, (such as interaction of the cannula sheath with a concomitant vessel dilator or guide wire) may contribute to the failure as reported.According to the instructions for use (ifu), ¿a vessel dilator facilitates the percutaneous entry of the csi by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.If increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.¿ based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.
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