Qn#: (b)(4).Visual analysis of the guide wire revealed three major kink/bends in the wire body, as well as a misshaped j-bend.No obvious defects or anomalies were observed on the catheter.Microscopic examination confirmed the kinks and revealed that the distal and proximal welds appeared spherical and intact.The guide wire total length measured 602mm (ruler: (b)(4)), which is within the specification limits of 596mm-604mm per the guide wire graphic (b)(4) rev.03.The guide wire outer diameter (od) measured 0.81mm (caliper: (b)(4)), which is within the specification limits of 0.788mm-0.826mm per the guide wire graphic wgz-04432-001a rev.03.The catheter body length from the juncture hub to the blue-flex tip measured 215mm (ruler: (b)(4)), which is within the specification limits of 207mm-227mm per the catheter graphic (b)(4) rev.15.The catheter body outer diameter measured 2.40mm (caliper: (b)(4)), which is within the specification limits of 2.36mm-2.46mm per the catheter extrusion graphic (b)(4) rev.04.The distal extension line of the returned catheter was found plugged with biological material.A wire guide and 10ml syringe were used to unblock the extension line.After removing the biological material, both extension lines were flushed with water and functioned as expected.The returned guide wire was passed through the distal extension line only encountering resistance at the kinks in the wire guide body.A manual tug test confirmed that the proximal and distal welds were secure and intact.The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed one major kink and two bends in the wire guide body.The catheter and the guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the sample received and the customer report, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Corrective action is not required at this time as unintentional user error likely caused or contributed to this event.
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