GUARDIAN II

Description of Event or Problem

IT WAS REPORTED BY A PERSON AT THE HEALTH CARE FACILITY, "CASE DESCRIPTION: "59 YEARS OLD, WITH A HISTORY OF DIABETES, HYPERTENSION, HYPERLIPIDEMIA, AND SMOKING. ADMITTED FOR ELECTIVE CATHETERIZATION FOLLOWING SUSPECTED CORONARY OCCLUSION ON CARDIAC CT. ON (B)(6) 2024, DIAGNOSTIC CATHETERIZATION DEMONSTRATED 80-90% CALCIFIED STENOSIS IN THE LAD. INTERVENTIONAL CATHETERIZATION AND OPENING OF THE LAD OCCLUSION WERE RECOMMENDED, WHICH THE PATIENT ACCEPTED. WHEN CONTRAST MEDIUM WAS INJECTED, NO FLOW WAS DEMONSTRATED IN THE LEFT CORONARY SYSTEM. THE PATIENT IMMEDIATELY EXPERIENCED HEMODYNAMIC AND RESPIRATORY COLLAPSE; CARDIAC SHOCK ACCOMPANIED BY VENTRICULAR FIBRILLATION ARRHYTHMIA. CPR EFFORTS WERE INITIATED, WHICH INCLUDED HEART MASSAGE, INTUBATION, AND VENTILATION BY AN ANESTHESIOLOGIST. VASOPRESSOR DRUG THERAPY WAS GIVEN WITH REPEATED ROUNDS OF ADRENALINE, BICARBONATE, AND ANTIARRHYTHMIC THERAPY (AMIODARONE). DURING RESUSCITATION, 3 STENTS WERE IMPLANTED, AN INTRA-AORTIC BALLOON WAS INSERTED, AND A TEMPORARY PACEMAKER WAS INSERTED. UNDER THIS TREATMENT, NORMAL FLOW WAS DEMONSTRATED IN THE LEFT CORONARY SYSTEM. AT THE END OF THE CATHETERIZATION, THE PATIENT WAS ANESTHETIZED AND VENTILATED. PH6.8, POTASSIUM 1.9, PCO2 CLOSE TO 70 (DECREASING). UNDER THE SUPPORT OF INTRA-AORTIC BALLOON, BLOOD PRESSURE AROUND 140/60, DUFFER 120 PER MINUTE, TRANSFERRED TO INTENSIVE CARE. THE FAMILY WAS INFORMED ABOUT THE PROGRESS OF THE CATHETERIZATION AND THE PATIENT'S CONDITION. TOWARDS 6:30 PM, BRADYCARDIA WAS OBSERVED, A PULSE WAS NOT PALPABLE LATER, CPR WAS INITIATED, HE RECEIVED REPEATED DOSES OF ADRENALINE AND BICARBONATE, AND AFTER 35 MINUTES, THE PULSE DID NOT RETURN, WITHOUT CONTRACTION ON ECHOCARDIOGRAPHY, AND HIS DEATH WAS DETERMINED AT 5:35 PM."

Additional Manufacturer Narrative

(B)(4). NO RETURN PRODUCT EVALUATION COULD BE COMPLETED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED, AS NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. COMPLAINT DETAILS WERE REVIEWED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED BY A PERSON AT THE HEALTH CARE FACILITY, "CASE DESCRIPTION: "59 YEARS OLD, WITH A HISTORY OF DIABETES, HYPERTENSION, HYPERLIPIDEMIA, AND SMOKING. ADMITTED FOR ELECTIVE CATHETERIZATION FOLLOWING SUSPECTED CORONARY OCCLUSION ON CARDIAC CT. ON (B)(6) 2024, DIAGNOSTIC CATHETERIZATION DEMONSTRATED 80-90% CALCIFIED STENOSIS IN THE LAD. INTERVENTIONAL CATHETERIZATION AND OPENING OF THE LAD OCCLUSION WERE RECOMMENDED, WHICH THE PATIENT ACCEPTED. WHEN CONTRAST MEDIUM WAS INJECTED, NO FLOW WAS DEMONSTRATED IN THE LEFT CORONARY SYSTEM. THE PATIENT IMMEDIATELY EXPERIENCED HEMODYNAMIC AND RESPIRATORY COLLAPSE; CARDIAC SHOCK ACCOMPANIED BY VENTRICULAR FIBRILLATION ARRHYTHMIA. CPR EFFORTS WERE INITIATED, WHICH INCLUDED HEART MASSAGE, INTUBATION, AND VENTILATION BY AN ANESTHESIOLOGIST. VASOPRESSOR DRUG THERAPY WAS GIVEN WITH REPEATED ROUNDS OF ADRENALINE, BICARBONATE, AND ANTIARRHYTHMIC THERAPY (AMIODARONE). DURING RESUSCITATION, 3 STENTS WERE IMPLANTED, AN INTRA-AORTIC BALLOON WAS INSERTED, AND A TEMPORARY PACEMAKER WAS INSERTED. UNDER THIS TREATMENT, NORMAL FLOW WAS DEMONSTRATED IN THE LEFT CORONARY SYSTEM. AT THE END OF THE CATHETERIZATION, THE PATIENT WAS ANESTHETIZED AND VENTILATED. PH6.8, POTASSIUM 1.9, PCO2 CLOSE TO 70 (DECREASING). UNDER THE SUPPORT OF INTRA-AORTIC BALLOON, BLOOD PRESSURE AROUND 140/60, DUFFER 120 PER MINUTE, TRANSFERRED TO INTENSIVE CARE. THE FAMILY WAS INFORMED ABOUT THE PROGRESS OF THE CATHETERIZATION AND THE PATIENT'S CONDITION. TOWARDS 6:30 PM, BRADYCARDIA WAS OBSERVED, A PULSE WAS NOT PALPABLE LATER, CPR WAS INITIATED, HE RECEIVED REPEATED DOSES OF ADRENALINE AND BICARBONATE, AND AFTER 35 MINUTES, THE PULSE DID NOT RETURN, WITHOUT CONTRACTION ON ECHOCARDIOGRAPHY, AND HIS DEATH WAS DETERMINED AT 5:35 PM."

Additional Manufacturer Narrative

(B)(4)