It was reported that in the icu during insertion into the (b)(6) male patient the tip of the dilator was damaged.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.
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(b)(4).Device evaluation: the reported complaint that the guide wire lost its shape and that the dilator tip was damaged during insertion was confirmed.The customer returned one guide wire and one dilator.Visual examination revealed that the guide wire is kinked in the middle of the wire and that the dilator is bent and the tip is damaged.A manual tug test of the guide wire revealed that the proximal weld was intact but the distal core wire felt separated.Microscopic examination of the guide wire confirmed the kinks and that the core wire is broken from the distal weld.Microscopic examination also found that the welds were both full and spherical and that a discoloration and necking of the core wire was observed in the area of the break.Discoloration at the broken end of the core wire is consistent with proximity to a weld.Kinks were observed at 11.0, 39.3, 40.5, 42.4, 44.5 cm from the distal end of the core wire.The core wire measured 601 mm in length, which meets the length specification of 596- 604 mm per the guide wire graphi c; therefore, no pieces appear to be missing.The diameter of the guide wire measured 0.802 mm, which is within the outside diameter specification of 0.788mm - 0.826 mm per the guide wire graphic.The dilator body was bent at approximately 8.0 cm from the hub other remarks: base and again just before the tip; approximately 1.5 cm from the tip edge.Microscopic examination confirmed that the tip edge was stretched, folded and flattened.The tip edge also had white material from force or stress being applied.A functional test was performed by inserting the proximal end of the returned guide wire through the dilator with no resistance.The instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use and states to enlarge the puncture site with the cutting edge of a scalpel positioned away from the guide wire which is already inserted into the patient.The insertion procedure used was not reported and therefore it is not known if a skin nick was performed prior to the dilator insertion.The device history records for the guide wire and dilator assembly were reviewed with no findings relevant to this complaint.The investigation found no evidence to suggest a manufacturing related cause.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.Based on the time of discovery and the information provided, operational context caused or contributed to this complaint.No further action will be taken.
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