BEUDAMED
    FDA Adverse Event Death Summary report: Y

    SURFACER® INSIDE-OUT® ACCESS CATHETER SYSTEM.BLUEGRASS VA

    MDR report key: 19997507 · Received August 15, 2024

    Report

    Report Number
    1721504-2024-00052
    Event Type
    Death
    Date Received
    August 15, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    QJH
    PMA / PMN Number
    DEN190038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION, THE DEVICE IS BEING HELD AT ACCOUNT FOR FURTHER EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING A CENTRAL VENOUS ACCESS ATTEMPT FOR PLACEMENT OF A CENTRAL VENOUS CATHETER, VASCULAR ACCESS WAS OBTAINED VIA THE STANDARD SELDINGER TECHNIQUE. A GUIDEWIRE WAS ADVANCED THROUGH A MICROPUNCTURE INTRODUCER AND THE FEMORAL INTRODUCER WAS THEN REMOVED. A SHEATH WAS THEN INTRODUCED INTO THE FEMORAL VEIN AND ADVANCED OVER THE WIRE UP TO THE APPROXIMATE LOCATION OF THE HIGH IVC. A VENOGRAM WAS PERFORMED AND SHOWED A SHEATH TIP NEAR THE RIGHT ATRIUM. A STANDARD CATHETER WIRE TECHNIQUE WAS USED TO NAVIGATE TO THE SUPERIOR VENA CAVA [SVC] AND POINT OF OCCLUSION. ANESTHESIA ADVISED THE PHYSICIAN OF UNUSUAL AND IRREGULAR HEART RHYTHM. THE PROCEDURE WAS PAUSED TO DETERMINE IF THE CASE SHOULD CONTINUE. THE ARRHYTHMIA SUBSIDED AND THE CASE PROCEEDED. THE CENTRAL VENOUS ACCESS WORKSTATION WAS THEN PREPPED. A REPEAT VENOGRAM WAS THEN PERFORMED WITH AN ANGLED GLIDE CATHETER CONFIRMING THE SVC TYPE III OCCLUSION. A SHEATH WAS THEN ADVANCED OVER THE WIRE COAXIALLY TO THE SVC OCCLUSION SITE. THE CENTRAL VENOUS ACCESS WORKSTATION WAS INTRODUCED AND ADVANCED TO THE TIP OF THE SHEATH. THE EXIT SITE MARKER WAS THEN PLACED ON THE PATIENT IN THE SUPRACLAVICULAR SPACE. UNDER FLUOROSCOPIC GUIDANCE, THE PHYSICIAN GENTLY ADVANCED THE CENTRAL VENOUS ACCESS WORKSTATION THROUGH THE OCCLUSION BRINGING THE TIP JUST INTO THE SUPRACLAVICULAR SPACE. CRANIAL AND ANTERIOR OBLIQUE ANGLES WERE PERFORMED TO CONFIRM THE CORRECT LOCATION OF THE EXIT SITE MARKER. A COMPLETE LATERAL FLUOROSCOPIC VIEW WAS PERFORMED CONFIRMING THE ANATOMICAL POSITION OF THE DEVICE. ULTRASOUND WAS THEN TO ASSESS FOR COLLATERAL VESSELS OR OTHER ANATOMICAL STRUCTURES. THE IMAGE INTENSIFIER WAS THEN RETURNED TO THE ORIGINAL ANGULATION. ROTATION OF THE CENTRAL VENOUS DEVICE TOWARD THE ANGLE OF THE IMAGE INTENSIFIER WAS PERFORMED. THE EXIT NEEDLE GUIDE KNOB WAS DIALED AT THE CRANIAL ANGLE. THE PLUNGER WAS THEN ADVANCED TWICE BRINGING THE WIRE TO THE SKIN LEVEL WHERE "TENTING" WAS OBSERVED. A PAIR OF HEMOSTATS WAS PLACED OVER THE EXIT SITE, THE WIRE WAS THEN ADVANCED BRINGING THE WIRE OUT OF THE PATIENT'S ANATOMY AS INTENDED. APPROXIMATELY 20CM OF WIRE WAS ADVANCED OUT OF THE PATIENT, AND A PEELAWAY SHEATH WAS PLACED OVER THE ACCESS WIRE. THE WORKSTATION WAS RETRACTED ENOUGH FOR THE "PEELABLE SHEATH" TO BE SUCCESSFULLY PULLED BACK INTO THE CENTRAL VENOUS SYSTEM DEVICE. THE CENTRAL VENOUS ACCESS WORKSTATION WAS REMOVED FROM THE PATIENT THROUGH A FEMORAL ACCESS SHEATH. THE JUGULAR ACCESS DILATOR WAS REMOVED AND THE PHYSICIAN BEGAN INSERTING A TUNNELED CVC CATHETER THROUGH THE ACCESS SHEATH TO THE PATIENT'S LOWER SVC. POST SHEATH ACCESS AND VESSEL DILATATION, ANESTHESIA ALERTED THE PHYSICIAN OF HEMODYNAMIC INSTABILITY. A CODE WAS THEN ACTIVATED. FEMORAL AND BRACHIAL CUTDOWN WAS ATTEMPTED FOR ADDITIONAL INTRAVASCULAR SUPPORT AND FURTHER FLUOROSCOPIC IMAGING BUT THE PATIENT'S CLOTTING FACTORS HAD BLOCKED ALL EXTERNAL ACCESS EFFORTS. THE PATIENT EXPIRED THE SAME DAY. THE PHYSICIAN ALLEGES THAT THERE WAS A SUSPECTED ASSOCIATION BETWEEN THE CENTRAL VENOUS ACCESS DEVICE USE AND THE PATIENT'S DEATH. THE EXTRAVASCULAR DEPLOYMENT WIRE LIKELY RESULTED IN A GREAT VESSEL INJURY THAT LED TO A MASSIVE AND FATAL HEMOTHORAX AS STATED BY A PRELIMINARY AUTOPSY. NO CENTRAL VENOUS DEVICE MALFUNCTION WAS ALLEGED DURING THIS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618971 SURFACER® INSIDE-OUT® ACCESS CATHETER SYSTEM.BLUEGRASS VA REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH MERIT MEDICAL SYSTEMS INC. 3405410000R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death| R