Qn#(b)(4).The customer returned a guide wire in an advancer.The guide wire was initially stuck in the straightening tube by dried blood.Once the guide wire was removed it was observed to be kinked at 1.8, 2.5, 12 and 15cm from the bottom of the j-bend.The outside diameter (od) of the guide wire measured 0.800mm, which met specification.The length of the guide wire measured 60.2cm, which is consistent with the graphic.A manual tug test confirmed that both welds were intact.A device history record (dhr) review was performed on the guide wire based on sales history and did not reveal any manufacturing related issues.The report that the guide wire kinked during insertion was confirmed through examination of the returned sample.The guide wire was kinked at multiple locations.A dhr review was performed based on sales history and it did not reveal any manufacturing related issues.Since the guide wire is always inserted through another component during the procedure and no other components were returned, the probable cause of this issue could not be determined.
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