A 5f pig 110cm 6sh supertorque mb catheter broke in two, during removal from the patient.The surgeon was able to recover the other part, via the femoral.There was no reported patient injury.The products were not returned for analysis.A product history record (phr) review of lot 18061731 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)- catheter (body/shaft)¿ could not be confirmed.Procedural factors and/or vessel characteristics factors may have contributed to the reported event.When resistance is met, the operator should take great care before applying more force during withdrawal.Magnified fluoroscopy will usually identify the point/ source of resistance.Often advancing the catheter rather retraction can resolve the issue.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
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