There was difficulty when advancing the optease retrievable filter and it punctured the sheath during delivery of the filter.The filter was withdrawn and replaced with another sheath to complete the procedure.The filter was placed for deep vein thrombosis.The patient was not morbidly obese and the approach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 discarded.The product was not returned for analysis.A product history record (phr) review of lot 17911452 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¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Based on the information available for review, procedural factors, such as operator technique, may have contributed to the event.According to 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 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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