The company identified a number of anatomical factors that could contribute to catheter helix fracture and/or breakage. It reports 30 serious injuries and four deaths associated with the issue. Additionally, BD reported 115 cases requiring additional intervention following helix fracture and/or breakage.
As part of a communications pilot, the FDA issued a notice regarding the high-risk device issue. BD sent affected customers a medical device correction letter on Feb. 5. That letter identified certain patient anatomical characteristics that may lead to helix fracture and/or breakage events. Those characteristics include vessel size, angulation, tortuosity, degree of calcification, and procedural factors such as contralateral access, sheath kinking, lack of continuous blood flow and catheter advancement related factors.
The helix rotates at a high rate of speed. Risk of fracture or breakage may occur when exposed to certain stress, wear, temperatures, friction or localized pressure. Certain anatomy types and procedural factors may cause this too. This could cause vessel injury and may lead to severe bleeding or death.
Rotarex breaks up and removes thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.
BD continues to investigate the contributing factors that may result in this issue. It instructed users to use a kink-resistant, suitably reinforced sheath of the same size as the Rotarex atherectomy catheter of 1 French size larger. Users should also maintain adequate blood flow through the catheter to reduce the risk of catheter overheating or blockage.
The company said users should maintain constant catheter movement to reduce fatigue stress on the inner helix in one location. They should monitor the catheter closely for resistance to movement as well.
