Subsequent to the initial report, return device analysis found the stent delivery system (sds) was returned with blood in the balloon folds, in the guide wire lumen.There was contrast on the device.The procedure was to treat an 80% stenosed lesion in the left anterior descending (lad) artery.No additional information was provided.
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A visual inspection was performed on the returned device.The reported material separation was confirmed.A review of the production records was performed and revealed no related complaint assessment or manufacturing nonconformities.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported material separation.It was reported that the stent delivery system¿s shaft separated during removal from the dispenser.Factors that may contribute to a shaft separation during unpackaging include, but are not limited to, damage incurred during manufacturing, damage incurred during shipment, or inadvertent mishandling during unpacking or preparation.In this case, analysis of the returned device noted the fracture face of the separation to be oval.This type of damage is consistent with force applied at a kink or bend.It is possible that inadvertent mishandling during unpackaging contributed to the reported shaft separation and the noted inner/outer member damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: patient code 2645 was removed and the patient code 2199 was added.
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