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(b)(4).
"the swg unraveled after withdrawing from introducer needle.
The customer returned a used unraveled spring wire guide (swg).
The introducer needle was not returned.
Visual examination of the swg revealed the guide wire is unraveled from the distal weld.
The distal end of the core wire protruding was flat and retained its j shape.
The guide wire body also has multiple bends in the inner core wire and stretched coils.
Microscopic examination of the swg confirmed the inner core wire fractured off adjacent to the distal weld.
The distal weld was present at the end of the unraveled coil wire and the proximal weld was still intact.
Both the proximal and distal welds appeared full and spherical.
The broken core wire measured 603mm in length, which met specification; therefore no pieces appear to be missing.
The outside diameter (od) of the guide wire measured 0.
794mm, which met specification.
A manual tug test confirmed that the distal weld was intact.
A device history record review was performed and no relevant findings were identified.
The instructions for use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.
It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.
In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3cm and then attempt to remove the guide wire.
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 was unraveled was confirmed through examination of the returned sample.
The guide wire core wire was broken adjacent to the distal weld.
Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.
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, operational context likely contributed to this event, however, the probable cause of guide wire and introducer needle resistance could not be determined based upon the information provided and without the introducer needle being returned.
Teleflex will continue to monitor and trend for reports of this nature.
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