No code available - suggested code: procedural delay.The oad was received at csi for analysis without protective packaging.Visual examination of the saline sheath revealed axial compression damage and deformation at the distal end of the saline sheath.Although the root cause of the saline sheath damage is undetermined, it is hypothesized that the damage is a result of applying excessive tension to the shaft and system during an attempt to remove the device and guide wire or the result of attempting to advance the device through a tight location.It is possible the saline sheath damage may have contributed to the reported event; however, this could not be confirmed through analysis.The oad driveshaft did not exhibit any damage that would have prevented a guidewire from passing through, and an in-house test wire was advanced into the driveshaft and handle assembly without resistance.As the original guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the reported complaint.At the conclusion of the failure analysis investigation, the reported driveshaft kink and inability to advance the guide wire through the oad could not be confirmed through analysis.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4).
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