During advancement of a 7f railway sheathless access system, a spasm occurred and hence, it could not cross.The spasm was treated with nitroglycerin (ntg).The procedure was completed using a femoral approach.The patient was normal after the procedure.A percutaneous transluminal coronary angioplasty (ptca) procedure was being performed.The access site did not have thrombus, extreme tortuosity or calcified plaque.There was no evidence of inadequate circulation to the extremity as evidenced by signs of artery occlusion or absence of radial pulse before insertion of the device.There was no difficulty removing the components from the packaging and none of the components appeared damage before use.The dilator was flushed prior to use.The hydrophilic coating was hydrated with heparinized saline or similar isotonic solution prior to use.Access with the.021¿ mini guidewire was already achieved when the spasm occurred.A non-cordis guide catheter was used in the procedure.The device will be returned for evaluation.Patient demographics including the reason for the procedure were not available.
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During the advancement of a 7f railway sheathless access system, a spasm occurred and the railway could not cross.The spasm was treated with nitroglycerin (ntg).The procedure was completed using a femoral approach.A percutaneous transluminal coronary angioplasty (ptca) procedure was performed.The access site did not have thrombus, extreme tortuosity or calcified plaque.There was no evidence of inadequate circulation to the extremity as evidenced by signs of artery occlusion or absence of a radial pulse before insertion of the device.There was no difficulty removing the components from the packaging and none of the components appeared damaged before use.The dilator was flushed prior to use.The hydrophilic coating was hydrated with heparinized saline or similar isotonic solution prior to use.Access with the.021¿ mini guidewire was already achieved when the spasm occurred.A non-cordis guide catheter was used in the procedure.Patient demographics including the reason for the procedure were not available.There was no reported patient injury.The device was returned for analysis.Two non-sterile railway access kit, 7f, vbt, hw wire devices were received.Per visual analysis no anomalies were observed.A product history record (phr) review of lot 17889356 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿arterial spasm¿ was not confirmed by analysis due to the nature of the complaint.The exact cause of the reported event could not be conclusively determined.Procedural factors, such as operator technique, or vessel characteristics, may have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿if the device becomes kinked or increased resistance is felt upon insertion or advancement of the vessel dilator, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the vessel dilator.¿ additionally, vascular complications such as vessel spasm can occur with this device and are mentioned in the ifu.Neither the phr nor the product analysis available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
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