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, frequency 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 a damaged guidewire was confirmed and the cause appeared to be use related.The product returned for evaluation was a set of photographs showing a break in both the coil wire and core wire.The physical sample was subsequently returned.The core wire broke 2.1cm from the weld tip.The distal segment of the guidewire was received in the needle.The outside diameter of the guidewire was measured near the weld tip and was found to be within specification.The coil wire had kinked at the needle bevel.After removing the wire from the needle, a microscopic examination revealed deformation in the needle bevel.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.Reference (b)(4) for further information regarding this failure mode.One of the precautions in the ifu states, ¿if the guidewire must be withdrawn while needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of rebs0001 showed no other similar product complaint(s) from this lot number.
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It was reported that during the installation of the picc catheter, after the puncture, it was made the introduction of the entire path and at the time of sliding, it feels that it attaches in the walls of the needle with difficulty to pass.So it was decided to remove the guide (with much resistance).The needle was slid along with the guide and the detachment of the soft part of the guide is observed and it get attached to the needle.Another device is installed with no adverse event that could damage the patient's health.Update 04/30/2018 - the returned guidewire is unraveled and has a break in the tip.
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