(b)(4).The customer returned a guide wire, a 4-l catheter, and a product lidstock for evaluation.The guide wire was partially advanced within the catheter and was unraveled.The components showed evidence of use in the form of dried blood.Visual examination revealed the guide wire was unraveled from the distal weld and was kinked/distorted in several locations along the body.The core wire distal j-bend was deformed and exposed out of the coil wire.The returned catheter shows evidence of use but no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip was discolored at the point of separation.Both welds were present and appeared full and spherical.Microscopic examination of the catheter and insertion components did not reveal any defects or anomalies.The major kinks in the guide wire body were measured at 60mm and 360mm from the proximal tip.The broken core wire measured 602 mm in length which is within the specification of 596- 604 mm per guide wire product drawing; therefore , no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.794 mm which is within the specification of 0.788-0.826 mm per guide wire product drawing.The catheter body length measured 212 mm which is within the specification of 207-227 mm per catheter product drawing.The undamaged portions of the returned guide wire passed through the distal extension line and catheter body of the returned catheter with minimal resistance.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and catheter met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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