The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of the catheter being perforated by the guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Blood residue was observed throughout the sample.The catheter was partially extended on the needle shaft.The tip of the wire protruded from the catheter.A loop of wire protruded from a longitudinally aligned split in the catheter near the distal end.Microscopic inspection of the distal end of the catheter revealed deformation and discoloration.The loop of guidewire extended from a tear in the catheter.Deformation and discoloration were observed in the vicinity of the tear.A break was observed in the inner core wire and the coil wire was elongated.The weld tip was intact.Inspection of the break in the core wire revealed a granular fracture surface.The fracture exhibited a region of increased luster.Inspection of the needle bevel outward flaring deformation along the proximal edge.The guidewire and catheter deformation were consistent with attempted device insertion against resistance.Such resistance can occur if insertion into tissue is attempted and if insertion is attempted at a steep insertion angle.The needle bevel damage and guidewire breakage were consistent with damage initiated by withdrawal of the wire against the needle bevel.The product ifu states ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.¿ a lot history review (lhr) of recs0355 showed no other similar product complaint(s) from this lot number.
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