Qn#1900068970 the customer returned one guide wire for analysis.The catheter involved with this complaint was not returned for analysis.Visual analysis of the sample revealed that the guide wire was unraveled from the proximal end.The j-bend at the distal end appeared normal.Microscopic examination revealed that the core wire had separated from the proximal weld.Despite this, the proximal weld was still attached to the core wire.The point of separation on the core wire contained stress marks and was slightly appears tapered, indicating that undue force likely caused the event.Small traces of biological material were also observed between the coils on the guide wire body.No other defects or anomalies were observed.The broken core wire measured 601 mm in length, which is within specification; therefore no pieces of the core wire appear to be missing.The outside diameter (od) of the guide wire was also within specification.A manual tug test revealed that the distal weld was intact and secure to the assembly.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with the kit warns the user "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested." additionally, the guide wire cautions, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guide wire was unraveled was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was indeed unraveled towards the proximal end.The guide wire met all relevant dimensional requirements; however functional inspection could not be performed as the catheter was not returned for analysis.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.Despite these circumstances and the customer description, the root cause still cannot be determined as the catheter was not returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
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