BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 11131878 · Received January 7, 2021

    Report

    Report Number
    3004936110-2021-00013
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    December 16, 2020
    Report Date
    March 5, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERFORATION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    DURING A CARDIOMEMS IMPLANT PROCEDURE, A CARDIAC PERFORATION OCCURRED, AND THE IMPLANT WAS ABANDONED DUE TO THE COMPLICATIONS. WHEN THE PATIENT WAS BROUGHT INTO THE LAB FOR HER PROCEDURE, SHE COMPLAINED VERBALLY BEFORE THEY BEGAN. SHE COMPLAINED OF PAIN IN HER BACK, LOWER LIMBS, AND DIFFICULTY BREATHING. THE PHYSICIAN ORDERED PAIN MEDICATION AND CONSULTED FURTHER WITH THE FELLOW REGARDING THE PATIENT'S STATUS. THE PHYSICIAN DECIDED TO MOVE FORWARD WITH THE PROCEDURE. WHILE THE CASE, THE PATIENT PERIODICALLY COMPLAINED VERBALLY. AN ULTRASOUND WAS USED TO GAIN RIGHT FEMORAL VENOUS ACCESS AND A 12F STANDARD LENGTH SHEATH WAS PLACED AT THE ACCESS POINT. A 7F BALLOON WEDGE PRESSURE CATHETER WAS THEN INSERTED THROUGH THE 12F SHEATH TO BEGIN THE RIGHT HEART CATHETERIZATION (RHC) PORTION OF THE PROCEDURE. AS HE WAS PERFORMING THE RHC, IT WAS OBSERVED THE PATIENT HAD A LARGE RIGHT ATRIUM (CONFIRMED VIA X-RAY AS WELL). THE LARGE RIGHT ATRIUM ALLOWED THE BWP CATHETER TO PROLAPSE ON ITSELF, WHICH MADE IT MORE DIFFICULT TO ADVANCE FURTHER IN THE VASCULATURE. HOWEVER, THE CATHETER WAS ABLE TO BE GUIDED INTO THE RIGHT ATRIUM, RIGHT VENTRICLE, AND PULMONARY ARTERY. EVENTUALLY, THE CATHETER WAS GUIDED INTO THE LEFT BRANCH OF THE PULMONARY ARTERY AND A PULMONARY ANGIOGRAM WAS PERFORMED TO IDENTIFY A POTENTIAL IMPLANT SITE FOR THE CARDIOMEMS PA SENSOR. AFTER IDENTIFYING AN IMPLANT SITE FOR THE CARDIOMEMS DEVICE, THE GLIDEWIRE WAS REMOVED AND AN .018 WIRE 300 CM WAS INSERTED. SEVERAL ATTEMPTS WERE MADE TO GUIDE THE .018" WIRE INTO THE SELECTED BRANCH OF THE LEFT PULMONARY ARTERY, BUT THIS PROVED DIFFICULT SINCE THE ANATOMY WAS NOT EASILY ATTAINABLE AND THE CATHETER KEPT PROLAPSING, MAKING IT HARD TO USE AS A SUPPORTIVE RAIL IN THE ANATOMY. EVENTUALLY, THE .018" WIRE WAS PLACED INTO THE SELECTED ANATOMY. THE CATHETER WAS REMOVED, AND THE CARDIOMEMS DELIVERY CATHETER WAS INSERTED OVER THE .018"WIRE. UNDER X-RAY, THE CARDIOMEMS DELIVERY CATHETER WAS GUIDED TO THE LEFT BRANCH OF THE PULMONARY ARTERY BUT COULDN'T ADVANCE TO THE EXPECTED LOCATION AS IT WOULDN'T ADVANCE FAR ENOUGH DOWN INTO THE SELECTED VESSEL. THEREFORE, THE CARDIOMEMS DELIVERY CATHETER WAS REMOVED TO TRY A DIFFERENT APPROACH. ALL WIRES AND CATHETERS WERE REMOVED, AND THE PHYSICIAN STARTED OVER. A 12 FRENCH SHEATH WAS REQUESTED THAT WAS AN EXTENDED LENGTH (45 CM). HE USED THIS AT THE SAME RIGHT FEMORAL VENOUS SITE FOR ACCESS. HE WANTED THIS EXTENDED LENGTH SHEATH TO PROVIDE MORE SUPPORT FURTHER UP INTO THE PATIENT'S ANATOMY SINCE THE LARGE RIGHT ATRIUM KEPT PROLAPSING ANY CATHETERS/WIRES, THUS MAKING IT HARD TO ADVANCE/MANIPULATE THEM IN THE BODY. HE INSERTED THE EXTENDED 12 FRENCH SHEATH SO THAT THE TIP OF IT WAS IN THE PULMONARY ARTERY. AFTER GETTING THE 45 CM 12 FRENCH SHEATH INTO THE PULMONARY ARTERY, HE INSERTED THE CATHETER AGAIN AND GUIDED IT THROUGH THE RIGHT ATRIUM, RIGHT VENTRICLE, AND PULMONARY ARTERY. EVENTUALLY, THE CATHETER WAS ADVANCED INTO THE RIGHT PULMONARY ARTERY TO LOOK AT THE VASCULATURE TO SEE IF HE COULD DEPLOY THE CARDIOMEMS PA SENSOR ON THAT SIDE. HE TOOK A PULMONARY ANGIOGRAM OF THE RIGHT PULMONARY ARTERY TO SEE THE ANATOMY. AT SOME POINT AFTER THE NON-ABBOTT EXTENDED LENGTH 12 FRENCH SHEATH WAS INSERTED, THE PATIENT BEGAN TO COMPLAIN VERBALLY AGAIN WITH MORE URGENCY. AT THIS POINT, THE PATIENT WAS STARTING TO DECLINE IN STATUS. THE IMPLANT WAS STOPPED, AND CARDIAC RESUSCITATION WAS STARTED AS THE PATIENT'S CARDIAC FUNCTION DECLINED RAPIDLY (FAINT/LOST PULSE, LOW/LOST BLOOD PRESSURE) AND LOST CONSCIOUSNESS. CHEST COMPRESSIONS WERE INITIATED, EMERGENCY PERSONNEL WERE CONSULTED (ANESTHESIA, CARDIOVASCULAR SURGEON, INTERVENTIONAL CARDIOLOGIST, ELECTROPHYSIOLOGIST) AND MEDICATIONS WERE ADMINISTERED (E.G. EPINEPHRINE IN ADDITION TO MUCH MORE) IN AN ATTEMPT TO REVIVE THE PATIENT. AN ECHOCARDIOGRAM WAS PERFORMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY TO ASSESS WHAT OCCURRED. IT WAS DETERMINED THAT A PERFORATION LIKELY OCCURRED SOMEWHERE ON THE RIGHT SIDE OF THE HEART (RIGHT ATRIUM/RIGHT VENTRICLE/PULMONARY ARTERY) LEADING TO A CARDIAC TAMPONADE/PERICARDIAL EFFUSION. THE EMERGENCY INTERVENTION INCLUDED DRAINAGE OF THE CARDIAC TAMPONADE/PERICARDIAL EFFUSION, BLOOD INFUSION, CHEST COMPRESSIONS, AND ADMINISTERING OF VARIOUS MEDICATIONS. THEY WERE ABLE TO REVIVE THE PATIENT TO THE POINT OF MAINTAINING A PULSE AND BLOOD PRESSURE. THE DECISION WAS ULTIMATELY MADE TO MOVE THE PATIENT TO THE OPERATING ROOM TO CONSIDER FURTHER ASSESSMENT/INVESTIGATION AND INTERVENTION. THE PATIENT HAD FURTHER COMPLICATIONS POST-SURGICAL INTERVENTION FOR THE CARDIAC PERFORATION AND CURRENTLY HAS MULTI-SYSTEM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27021 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 7366623 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention