There was difficulty when advancing the optease retrievable filter 55 and it punctured the sheath during delivery of the filter.The filter was withdrawn and replaced with another one to complete the procedure.The patient was not morbidly obese and the approach was not tortuous.The product was stored and handled per instructions per use (ifu).There was no difficulty prepping the devices.The sheath was flushed prior to insertion into the patient and there was no difficulty inserting the filter into the sheath.There was no excessive force used.The filter was no longer within the storage tube when it punctured the delivery sheath.The device was returned for analysis.Per visual analysis, the obturator was already inserted on the sheath.A perforated condition was found on the cannula sheath by the filter barbs.No other anomalies were found along the device.No other component was returned for analysis.A functional analysis was not performed.Per microscopic analysis, amplified images were taken to a better observation of the perforated sheath.The type of damage present on the cannula is commonly caused during the interaction of the cannula material with a sharp object or mechanical damage, it seems the cannula material was punctured with a sharp object from the inside of the cannula, in this case the barbs of the filter, that could probably led to the perforated condition found on the received component.Additionally, the filter was viewed under the vision system, with special attention given to the barbs and no anomalies were found.A product history record (phr) review of lot 17881976 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event ¿filter ¿ impeded - perforated sheath¿ was confirmed since a perforated condition was found on the cannula during visual analysis.However, the exact cause of this condition could not be conclusively determined during the analysis.Procedural and/or handling factors, such as operator technique, might have contributed to the reported event since the device did not present any obvious indication of manufacturing defect or anomaly.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.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the design or manufacturing process of the unit; therefore, no corrective or preventive actions will be taken.
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