(b)(4).The customer returned a single guide wire and bag of melted components/packaging for evaluation.The customer noted that the plastic components had been unintentionally melted when they attempted to sterilize them.The guide wire was returned completely removed from the advancer assembly and part of the advancer assembly could be identified among the melted components.The introducer needle was not returned and the only needle that was returned (needle from catheter-over-needle assembly) had a melted hub.The guide wire was observed to have a single kink in the center of the body.The distal j-bend was undamaged and appeared as expected.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.Visual inspection of the introducer needle could not be performed as the needle was not returned for evaluation.The kink in the guide wire body was measured at 206 mm from the proximal tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The returned guide wire was advanced through a lab inventory 18ga introducer needle (same size as k-04300-012a from reported set) to functionally test the guide wire.The undamaged portion of the guide wire advanced through the needle with minimal resistance.Slight resistance was met while advancing the kinked portion.A manual tug test of the guide wire confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and all of the needles supplied in this set and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report that the guide wire kinked during use was confirmed through examination of the returned sample; however, the introducer needle was not returned for evaluation.The guide wire was kinked in one location at the center of the body.The returned guide wire met all relevant dimensional requirements and a device history record review of the guide wire and needle manufacturing processes did not identify any manufacturing related issues.Based on these circumstances , unintentional use error likely contributed to this event, however, the probable cause of guide wire and needle resistance could not be determined based upon the information provided and without the needle being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
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