(b)(4).The customer returned a guide wire and advancer.The guide wire was kinked at 2 and 26.5cm from the bottom of the j-bend.The outer diameter (od) of the guide wire measured 0.795mm , which met specification.The length measured 60.2cm, which was consistent with the graphic.A manual tug test confirmed that both welds were intact.Complaint verification testing could not be performed because the introducer needle was not returned for analysis.The customer returned the guide wire, which was kinked, indicating some difficulty was encountered during insertion.A dhr review found no evidence to indicate a manufacturing related cause.The probable cause of the guide wire kinking during insertion through the needle could not be determined based upon the information provided and without a complete sample.
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