(b)(4).The customer report of a kinked sheath was confirmed through investigation of the returned sample.The customer returned one sheath, dilator and cath lab sheath packaging for analysis.No definite signs of use were observed.Visual analysis revealed that the sheath contained two major kinks along the body.The locations of the kinks aligned with folding of the cath lab kit packaging.The damage appears consistent with defects caused by shipping and handling.The sheath body length from the hub to the distal tip measured 31 1/4" via calibrated ruler, which was within the specification limits of 30 7/8" - 31 7/8" per the sheath ext with dilator product drawing.The sheath body outer diameter in an area that was not crushed measured 0.165" via calibrated caliper, which is within the specification limits of 0.163"-0.167" per the sheath wrapped product drawing.Functional inspection was performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".The dilator was inserted through the proximal end of the sheath.The dilator met significant resistance at the flattened portion of the sheath but was able to pass through completely.The instructions for use (ifu) provided with this kit warns the user, "precaution: do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage.Do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary." a device history record review was performed and no relevant findings were identified.Therefore, based on the customer report and the sample received, shipping and storage likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
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