The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint an ¿unraveled¿ guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and the safety mechanism was engaged.The guidewire core wire was broken and the coil wire was elongated.The weld tip was intact.The core wire exhibited curved shape memory near the break site.Microscopic inspection of the break in the core wire revealed a granular fracture surface.A region of increased luster was observed.The break exhibited a tapered profile.Following removal of the safety mechanism, inspection of the needle bevel revealed mechanical damage along its proximal edge.The wire break characteristics and needle damage were consistent with damage initiated by withdrawing the wire against the needle bevel at a sharp angle.Such damage can occur if insertion is attempted a steep angle and the wire is withdrawn against the introducer needle.A lot history review (lhr) of recx1448 showed no other similar product complaint(s) from this lot number.
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