As reported, during a cardiomems implant procedure, following the initial insertion of the pulmonary wedge catheter, the physician determined that it would be necessary to change out the catheter to select a target vessel.The pulmonary artery (pa) catheter was removed, and a new unknown catheter was advanced through the right ventricle.At this time, it was noted that the patient was becoming bradycardic, and medications were given as a result.The implant procedure was completed.Additional medications were administered post procedure and the patient was admitted for observation due to continued bradycardia and hypotension.The physician reports the cause of the bradycardia was the advancement of the unknown judkins right (jr) cordis catheter.An unknown sv5 cordis guidewire was also used for the procedure.Without the return of the unknown jr cordis catheter or the sv5 wire for analysis, it cannot be confirmed if the adverse events of bradycardia and hypotension were related to device malfunctions and the exact cause cannot be determined.Contact between the heart tissue and the devices is a likely cause of these adverse events.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, ¿catheters- complications may occur at any time during or after the procedure.Possible complications include but are not limited to the following: air embolism, hematoma at the puncture site, infection, perforation of the vessel wall.Sv5- possible complications include, but are not limited to air embolism, hematoma at the puncture site, infection, perforation of the vessel wall.¿ based on the information available, 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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As reported, during a cardiomems implant procedure, following the initial insertion of the pulmonary wedge catheter, the physician determined that it would be necessary to change out the catheter to select a target vessel.The pulmonary artery (pa) catheter was removed, and a new unknown catheter was advanced through the right ventricle.At this time, it was noted that the patient was becoming bradycardic, and medications were given as a result.The implant procedure was completed.Additional medications were administered post procedure and the patient was admitted for observation due to continued bradycardia and hypotension.The physician reports the cause of the bradycardia was the advancement of the unknown judkins right (jr) cordis catheter.An unknown sv5 cordis guidewire was also used for the procedure.This information is sourced from a medwatch report.Additional information was not provided.The devices will not be returned for evaluation.
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