(b)(4).The customer returned one peel-away sheath for evaluation.Visual examination of the sheath revealed the tip was frayed outwards.The tip also contained white coloration.This damage is consistent with undue force being applied to the sheath tip during an attempted insertion.The total length of the sheath body measured to be 2.74" which is within specifications of 2.625-2.875" per product drawing.The outer diameter of the sheath body measured to be 0.102" which is within specifications of 0.094-0.104" per product drawing.The inner diameter of the distal tip could not be measured due to the damage observed.The returned dilator was able to advance and retract from the returned sheath with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "do not withdraw dilator until sheath is within vessel to minimize the risk of damage to sheath tip." the ifu also instructs the user to "enlarge puncture site, if necessary" using a scalpel prior to insertion of the sheath.This would mitigate the potential for damage to the sheath tip during insertion.The customer did not state whether this was performed.The ifu also provides technique suggestions for the sheath insertion: "thread tapered tip of peel-away sheath / dilator assembly over guidewire.Grasping near skin advance assembly with slight twisting motion to a depth sufficient to enter vessel.Dilator may be partially withdrawn to further facilitate advancement of sheath into the vessel.A slight twisting motion of the peel-away might help sheath advancement." the customer report of a damaged sheath tip was confirmed by complaint investigation of the returned sample.The peel-away sheath tip was frayed and contained damage consistent with undue force being applied during an attempted insertion.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.Based on the condition of the sample received and the customer report of the defect being identified during use, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
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