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The account reported finding damaged wire in a coronary angio pack and reported receiving a damaged guidewire.A sample was received for the investigation, and upon close inspection of the sample, a kink is noted on the curve of the j part of the wire; the pack production record was unable to be reviewed due to no lot number being provided, and the finished good pack build was reviewed.Based on the complaint details, sample evaluation and investigation, medline confirmed the reported issue.Medline determined that the item was either damaged prior to placement in the pack and was not noted during assembly or the item became damaged due to rough handling of the pack; the vendor concluded that the defects seen did not indicate a manufacturing issue, was unable to assign a definitive root cause, and no corrective actions were established at this time.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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