BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL VASCADE 5F VCS

    MDR report key: 14291985 · Received May 5, 2022

    Report

    Report Number
    3004182619-2022-00004
    Event Type
    Death
    Date Received
    May 5, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 4, 2022
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS NOT RELATED TO A DEVICE MALFUNCTION AND THE DEVICE WORKED AS INTENDED. A COMPLICATION SUCH AS HEMATOMA AND DEATH ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE PROCEDURE. PER THE REPORT, HEMOSTASIS WAS ACHIEVED WITH THE DEVICE.

    Description of Event or Problem · 0

    A LHC WAS PERFORMED USING A 5F TERUMO SHEATH. THE RIGHT FEMORAL ARTERY WAS ACCESSED USING A MICRO PUNCTURE NEEDLE WITH ULTRASOUND SOUND GUIDANCE. A POST PROCEDURE FEMORAL ANGIO WAS DONE PRIOR TO CLOSING THE RIGHT FEMORAL ARTERY. THE VASCADE 5F DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH. THE DISC WAS DEPLOYED, THE SHEATH WAS REMOVED, AND TEMPORARY HEMOSTASIS WAS ACHIEVED. THE VASCADE WAS DEPLOYED USING A TACTILE TECHNIQUE, MEANING THAT THE USER DID NOT USE FLUOROSCOPY, BUT INSTEAD VERIFY THAT THE DISK IS AGAINST THE ARTERY BY FEELING RESISTANCE AND CHECKING TO SEE IF THERE IS BLEEDING AT THE ACCESS SITE. THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN. THE PUSH ROD WAS UTILIZED TO STRIP THE COLLAGEN FROM THE DEVICE, AND THE DEVICE WAS REMOVED. HEMOSTASIS WAS OBTAINED ON THE PROCEDURE TABLE. THE TECHNOLOGIST PULLED THE DRAPE BACK AND NOTICED A SMALL GOLF BALL SIZE HEMATOMA DISTAL (ON THE TOP OF THE THIGH) TO THE ACCESS SITE. HE HELD ADDITIONAL PRESSURE AND THE PATIENT WAS MOVED FROM THE PROCEDURE TABLE. THE ACCESS SITE REMAINED SOFT AND THE GAUZE WAS DRY WHEN THE PATIENT PROCEEDED TO HOLDING. THE STAFF DID SAY THE PATIENT WAS HAVING ISSUES WITH LYING STILL THE ENTIRE PROCEDURE AND POST PROCEDURE. ABOUT 15 MINUTES LATER IN POST CARE, THE PATIENT HAD ANOTHER HEMATOMA DISTAL TO THE ACCESS SITE AGAIN (TOP OF THIGH) ROUGHLY ABOUT GOLF BALL SIZE. THE TECHNOLOGIST HELD AN ADDITIONAL 20MINS OF MANUAL PRESSURE. THE ACCESS SITE STILL REMAINED SOFT AND THE GAUZE WAS DRY AND INTACT. SEVERAL HOURS LATER ABOUT MIDNIGHT, THE STAFF/PHYSICIAN WAS CALLED BECAUSE THE PATIENT HAD A FOOTBALL SIZE HEMATOMA DOWN TO HER RIGHT KNEE AND WAS RUSHED TO EMERGENCY SURGERY. THE POST OP REPORT STATED THAT THERE WAS A SMALL DEFECT IN THE ARTERY AND WAS REPAIRED BY SUTURE. THE HEMATOMA WAS EVACUATED SURGICALLY. THE PATIENT LATER ON THAT MORNING CODED AND WASN'T ABLE TO RESUSCITATE AND WAS PRONOUNCED DECEASED. ADDITIONAL INFORMATION RECEIVED ON 5/3/22. PATIENT IS A (B)(6) FEMALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH STENTS, HYPERTENSION, HYPERLIPIDEMIA AND DM TYPE II. PATIENT PRESENTED ON (B)(6) 2022 FOR EVALUATION FOR CHEST PAINS. IN REVIEW OF RECORDS, PATIENT UNDERWENT STRESS TEST WHICH WAS FOUND TO BE ABNORMAL AND UNDERWENT PCI THROUGH RIGHT GROIN ON (B)(6) 2022. THERE WAS NO INTERVENTION DONE WITH RECOMMENDATIONS TO CONTINUE AGGRESSIVE MANAGEMENT. AROUND 10:30 PM, CODE BLUE CALLED AS PATIENT BECAME UNRESPONSIVE. PATIENT DID RECEIVE SEVERAL ROUNDS OF EPINEPHRINE (26), BICARB (3), CALCIUM (2), SHOCKED (5) AND GIVEN 4 UNITS OF PRBCS AND NS BOLUSES. PATIENT WAS FOUND TO HAVE A LARGE HEMATOMA AROUND HER RIGHT GROIN, AND PHYSICIAN CONSULTED. AFTER STABILIZATION, PATIENT TAKEN TO THE OPERATING ROOM FOR FEMORAL EXPLORATION S/P EVACUATION OF HEMATOMA AND REPAIR OF FEMORAL ARTERY WITH 2 JACKSON PRATT DRAIN PLACEMENT. PATIENT REMAINED IN CRITICAL CONDITION. ON (B)(6) 2022 POST OPERATING ROOM PATIENT REMAINED IN SHOCK STATE FOUND ON LEVO, VASO, AND EPI DRIPS. PATIENT HAD RECEIVED BLOOD PRODUCTS FOR DIC. PATIENT HAD MULTI-ORGAN FAILURE INCLUDING RENAL FAILURE ANURIA, HYPERKALEMIA AND WITH SEVERE METABOLIC ACIDOSIS. PATIENT SHIFTED FOR HYPERKALEMIA AND WAS ON BICARB DRIP FOR MET ACIDOSIS AND REQUIRED BICARB PUSHES AS WELL. PER VASCULAR SURGEON, NO FURTHER INTERVENTIONS. PATIENT WAS TOO UNSTABLE FOR DIALYSIS. PATIENT CODED AGAIN AND WAS DECLARED DEAD AT 10:47AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414244 CARDIVA MEDICAL VASCADE 5F VCS VASCADE 5F MGB CARDIVA MEDICAL, INC. 700-500DX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death