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.This is the only complaint reported to date for this lot number and failure mode.One crosser s6 catheter was returned.Investigation summary: the device was returned with the outer catheter separated from the distal tip.Twisting of the outer catheter was identified approximately 144.2cm from the strain relief.The marker band was dislodged from the base of the metal tip and loosely sliding along the distal end of the corewire.Therefore, the investigation is confirmed for material separation, dislodged or dislocated, and material twisting.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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