FEMORAL SHEATH FRACTURE DURING PTCA: A RARE DEVICE-RELATED ADVERSE EVENT

Introduction:A femoral sheath catheter is a flexible tubeinserted into the femoral artery or vein during cardiaccatheterization to facilitate catheter guidance into the heart.Itprovides temporary femoral arterial access and helps reducebleeding.The femoral artery is preferred for its large diameter,superficial location, and case of compression, with closuredevices used post-procedure. Case Summary:A 72 year old male patient with coronar artery disease and inferior wall acute myocardial infarction was admitted for PTCA. The procedure was completed withoutcomplications by trained personnel under the supervision of acardiac surgeon.The patient was transferred to the ICU,whereactive bleeding was noted at the femoral access site. Uponremoval of the femoral sheath, it was observed that the sheathwas fractured. Procedure was without complications and all the procedures were done by trained personnel under the guidance of Cardiac surgeon. Patient was shifted to ICU.Patient had bleeding and had Femoral sheath removal and after removal it was observed that the femoral sheath was broken. Management:Imaging confirmed the presence of the retainedbroken sheath fragment within the femoral artery.An exploratorysurgical procedure was performed to retrieve the fragment. Outcome:The patient required ventilator support postoperativelyand was successfully extubated after three days. Conclusion:Reporting rare complications like femoral sheath fractures to the Materiovigilance Program of India is essential for improving device safety and clinical outcomes.Such vigilance ensures better management and prevention of similar incidents.