The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed and was determined to be use related.One 0.035 in.¿j¿-tip guidewire was returned for evaluation.An initial visual observation showed use residue throughout the returned sample.The guidewire was observed to be bent and curved in multiple locations and a large portion of the coiled wire was observed to be unraveled.The core wires were observed to be broken, and a microscopic observation of the break sites of the core wires revealed they were both tapered with mostly flat and granular break surfaces, which is characteristic of tensile failure.The investigation findings are consistent with damage caused by retraction of the guidewire against resistance; possibly against the bevel of the introducer needle, specifically.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.The product ifu states: ¿do not pull back guidewire over needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.Withdraw needle and guidewire if cause of resistance cannot be determined.¿.
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