BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURFACER®

    MDR report key: 17393786 · Received July 25, 2023

    Report

    Report Number
    1721504-2023-00065
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 17, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    QJH
    UDI-DI
    00860003451601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE PATIENT EXPERIENCED AN ARTERIAL PERFORATION REQUIRING INTERVENTION AND ALSO SUFFERED A STROKE POST PROCEDURE DUE TO PHYSICIAN FAILURE TO PROPERLY ANTICOAGULANT THE PATIENT. THE PHYSICIAN STATES THAT THE DEVICE WAS SUCCESSFULLY ADVANCED FROM THE PATIENT'S RIGHT FEMORAL VEIN TO THE SITE OF THE OCCLUSION IN THE SVC. THE DEVICE WAS THEN ADVANCED THROUGH THE TARGETED OCCLUSION, AND THE TIP OF THE DEVICE WAS ADVANCED SUPERIOR TO THE RIGHT CLAVICLE. THE TIP OF THE DEVICE AND THE EXIT SITE TARGET WERE CORRECTLY ALIGNED UNDER FLUOROSCOPY AND THE NEEDLE WIRE WAS ADVANCED AND EXTERIORIZED WITH THE ASSISTANCE OF AN #11 BLADE AND A PAIR OF HEMOSTATS. THE PEEL AWAY SHEATH WAS THEN ADVANCED OVER THE WIRE TO THE PATIENT. HEMOSTATS WERE PLACED AT THE PROXIMAL END OF THE SHEATH CLAMPING THE WIRE IN PLACE. THE PHYSICIAN THEN LOCKED THE WIRE IN PLACE ON THE DEVICE AND PROCEEDED TO PULL THE SHEATH INSIDE THE PATIENT. THE PHYSICIAN THEN ADMINISTERED CONTRAST THROUGH THE SHEATH AND OBSERVED VASCULAR EXTRAVASATION DUE TO PERFORATION OF THE ARTERY. THE DEVICE WAS THEN REMOVED FROM THE PATIENT ENTIRELY AND THE INTERVENTIONAL CARDIOLOGY TEAM WAS URGENTLY CALLED TO ASSIST. THE TEAM SUCCESSFULLY DEPLOYED VASCULAR STENTS TO REPAIR THE ARTERIAL PERFORATION. THE PHYSICIAN BELIEVES HE INADVERTENTLY PERFORATED THE RIGHT INNOMINATE ARTERY WHILE MANIPULATING THE SURFACER DEVICE. HE ALSO BELIEVES HIS ACTIONS AND FAILURE TO PUSH HEPARIN DURING THE REST OF PROCEDURE MAY HAVE CAUSED THE PATIENT TO STROKE. THE EVENT WAS NOT A RESULT OF THE DEVICE MALFUNCTION. THE DEVICE PERFORMED AS INTENDED. THE PATIENT WAS TREATED WITH BENADRYL PRE-PROCEDURE DUE TO ALLERGIES TO VANCOMYCIN AND VARIOUS CONTRAST AGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622068 SURFACER® REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH MERIT MEDICAL SYSTEMS INC. BVT041923-01 00860003451601

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention