The hemo-cath was returned for evaluation.Visual inspection confirms the complaint as two leaks were noted on the arterial extension approximately 4 cm from the end of the luer.The two leaks are 180 degrees from each other.The contract manufacturer conducted a review of the manufacture records for the catheter lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformance's or abnormalities.The process includes a 100% leak test performed as a last step in the manufacture process.This test would have detected any leaks, holes, or weak spots if they had existed at the time of manufacture.The device was implanted for more than three months prior to the event.We are unable to determine the cause or factors that may have contributed to this event.In the past similar holes in the extension tubing were determined to be caused by the user clamping over the stylet or guidewire during the insertion procedure.The instructions for use (ifu) contains the following precautions: clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Do not clamp over guidewire or stylet - tubing may become damaged.Examine catheter lumen and extensions before and after each treatment for damage.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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