H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ptfe coated guidewire, in two pieces was returned for evaluation.Both segments of the guidewire had multiple bends and kinks along their lengths.The inner guidwire on one of the segments was exposed.The braiding of the guidewire on the other segment was unwound and loose.The investigation is confirmed for the alleged fracture of the guidewire core wire and the fraying of the outer wire of the guidewire.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: g4.H11: h3, h6 (results, conclusion).H11:section a through f - the information provided by bd 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 bd.
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