Qn# (b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The customer returned one opened cvc set with multiple components, including a guide wire, for analysis.The guide wire was returned within its advancer tube and showed evidence of use.Visual inspection of the guide wire revealed one kink in its body.The distal j-bend was slightly misshapen but intact.Both welds were present and appeared full and spherical.The kink in the guide wire measured 62mm via calibrated ruler from the distal end.The guide wire total length measured 450mm via calibrated ruler, which was within the specifications of 437.5-462.5mm per product drawing.The guide wire outer diameter (od) measured 0.52mm via calibrated caliper, which was within the specifications of 0.51-0.55mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was able to pass through a lab inventory arrow raulerson syringe (ars) and introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds were intact.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
|