As reported, a cardiologist reported a case of aortic dissection while using the 5f tempo (5f tempo 0.038 100c bl) brachial left catheter.The intended procedure was a coronary angiogram; the right radial was accessed.Several minutes after procedure, the patients¿ blood pressure dropped and patient passed out.St elevation was noted.The patient was transported to another hospital to fix the dissection by placing an unknown stent.The patient was transported due to that facility did not do pci, they only did the coronary angiogram (cag).The hospital the patient was transported to treated patient.The cag outcome showed rca irregularities, lad irregularities, contains a stent placed earlier, and rcx severe calcification.There was no vessel calcification, tortuosity or stenosis.The device was not used for a chronic total occlusion.The device was stored, handled, and prepped per the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package, and no anomalies noted during or after the device was prepped.Unusual force was not used at any time during the procedure; neither resistance met while advancing the device nor torquing required.Another device was used to complete the procedure.The event did not cause a clinically relevant increase in the duration of the procedure.The event caused a condition that required hospitalization or significant prolongation of existing hospitalization.A procedural cd is not available for review.The device is not available for evaluation.
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After further review of additional information received the following sections have been updated accordingly: a2, a3, a4, b4, d4, g3, g4, h1, h2, h3 and h6.As reported, a cardiologist reported a case of aortic dissection while using a 5f tempo (5f tempo 0.038 100c bl) brachial left catheter.The intended procedure was a coronary angiogram; the right radial was accessed.The blood pressure dropped, and the patient passed out.St elevation was noted.The patient was transported to another hospital to fix the dissection by placing an unknown stent.The patient was transported because the facility does not do percutaneous interventions (pci).They only did the coronary angiogram (cag).The receiving hospital treated patient.The cag outcome showed right coronary artery (rca) irregularities, left anterior descending artery (lad) irregularities, a preexisting stent, and severe right coronary artery calcification.There was no vessel tortuosity, or stenosis.The device was not used for a chronic total occlusion.The device was stored, handled, and prepped per the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package, and no anomalies noted during or after the device was prepped.Unusual force was not used at any time during the procedure.Resistance was not met while advancing the device and torquing was not required.Another device was used to complete the procedure.The event did not cause a clinically relevant increase in the duration of the procedure.The event caused a condition that required hospitalization or significant prolongation of existing hospitalization.The product was not returned for analysis.A product history record (phr) review of lot 18018751 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 ¿aortic dissection¿ could not be confirmed.Patient specific vessel characteristics and/or damaging the catheter tip during removal from the package may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Possible complications include but are not limited to the following: air embolism, hematoma at the puncture site, infection, perforation of 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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