Qn# (b)(4).The customer provided one photo as part of this investigation.Visual analysis revealed that the sheath tip was slightly frayed.Signs of use were also observed.The customer also returned one sheath/dilator assembly for analysis.Signs of use in the form of biological material was observed.Visual analysis revealed that the sheath tip was slightly frayed.Microscopic examination confirmed the damage and revealed white stress marks around the frayed area.This defect is consistent with damage due to undue force applied during insertion.The sheath length from the juncture hub to the distal tip measured 4 1/4", which is within the specification limits of 4"-4 1/4" per the sheath product drawing.The sheath tip inner diameter measured.118", which is within the specification limits of.117"-.118" per the sheath product drawing.The returned dilator was removed and reinserted through the valve end of the sheath.The dilator was able to pass through the sheath extrusion with little to no difficulty.Performed per ifu statement , "insert entire length of dilator through hemostasis valve into sheath pressing hub of dilator firmly into hub of hemostasis valve assembly.Place assembly on sterile field awaiting final sheath placement".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing guidewire, dilator, or sheath.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The ifu also states, "do not withdraw dilator until the sheath is well within the vessel to reduce the risk of damage to sheath tip".The report of a damage sheath tip was confirmed through complaint investigation.Visual analysis of the sample revealed that the sheath tip was slightly frayed.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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