(b)(4).The customer returned an opened kit containing various components including the guide wire.The guide wire was unraveled and showed evidence of use, however, none of the other returned components showed evidence of use, including the catheter.Visual examination revealed the guide wire is unraveled from the distal weld and is kinked in several locations along the body.The distal end of the core wire protruding was flat and retained the j shape.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld and that the weld was present at the end of the coil wire.Discoloration of the core wire was observed and both welds appeared full and spherical.The kinks were measured at 31, 35.8 and 58.6cm from proximal weld.The broken core wire measured 598mm in length, which is within the specification; therefore no pieces appear to be missing.The outside diameter (od) of the guide wire was also measured and was found to be within specification.Functional testing was not performed as part of this complaint investigation.A manual tug test revealed the proximal weld was intact.Other remarks: a device history record (dhr) review was performed on the guide wire and no relevant findings were identified.The instruction booklet 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.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.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 (b)(4):1999 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, it was determined that operational context caused or contributed to this event.
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