Same case as: 2134265-2014-06004.It was reported that catheter coating was not intact.During a bleeding embolization procedure, a 105/3.0/2.5/.021/20 renegade¿ catheter was selected to treat the target lesion.It was noted that the distal part of the catheter was not fully coated, so they could not put it in the angiography catheter.Another of the same 105/3.0/2.5/.021/20 renegade¿catheter was selected and the same issue occurred.The procedure was completed with a different device.No patient complications were reported.
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Updated: device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes.Device evaluated by mfr.: the device was returned for analysis.During visual examination, no issues were found upon inspection of the catheter under the strain relief for any kinks/breaks in the shaft.The catheter was inspected by rotating the shaft 360° for any kinks/bumps/damage along the shaft.No kinks or bumps were noted.However, it was observed that the coating felt thinner on the distal end of the shaft.Overall length was measured as 117cm.40.7cm is transition point length.Water was also flushed through catheter using a syringe and no leaks or blockages were noted.A 0.016 inch mandrel was inserted into the catheter and there were no blockages present inside catheter.A coating confirmation test was performed using crystal violet solution.Damaged and missing coated was present on the distal end of the catheter.This can be depicted from black shiny marks present on the catheter post crystal violet coating confirmation test.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Same case as: 2134265-2014-06004 it was reported that catheter coating was not intact.During a bleeding embolization procedure, a 105/3.0/2.5/.021/20 renegade (tm) catheter was selected to treat the target lesion.It was noted that the distal part of the catheter was not fully coated, so they could not put it in the angiography catheter.Another of the same 105/3.0/2.5/.021/20 renegade (tm) catheter was selected and the same issue occurred.The procedure was completed with a different device.No patient complications were reported.
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