BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

    MDR report key: 11361057 · Received February 22, 2021

    Report

    Report Number
    2522007-2021-00010
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 23, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DXE
    UDI-DI
    10827002265179
    PMA / PMN Number
    K961992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DXE. CONCOMITANT MEDICAL PRODUCTS: PHILLIPS GLIDE LIGHT 14FR. AND 16FR. LASERS AND SHEATH, COOK CURVED FEMORAL SHEATH (LR-CRVFEM001), COOK CURVE FEMORAL INTRODUCER SHEATH SET (LR-CSS16). PMA/510(K): K961992. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REMOVING THE LEAD IN THE RIGHT ATRIUM, DURING A LEAD EXTRACTION PROCEDURE, THE PHYSICIAN STARTED TO DETACH THE LEAD IN THE RIGHT VENTRICLE FROM A SUPERIOR APPROACH. HOWEVER, THE ADHESIONS NEAR THE TIP OF THE LEAD WERE SO STRONG THAT THE GLIDE LIGHT 14FR (LASER SHEATH/PHILIPS), WHICH WAS BEING APPROACHED FROM THE SUBCLAVIAN VEIN, GOT STUCK NEAR THE LEAD TIP AND WOULD NOT MOVE. THE PHYSICIAN TRIED TO REMOVE THE STUCK LEAD BY CHANGING TO AN FEMORAL APPROACH AND PULLING IT FROM BELOW THE VEIN OF THE INGUINAL REGION, USING THE REPORTED LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE (LR-NES001), BUT THEY WERE UNABLE TO THE LEAD. THE PHYSICIAN THEN USED A COOK CURVE FEMORAL INTRODUCER SHEATH SET (LR-CSS16) AND A COOK CURVED FEMORAL SHEATH (LR-CRVFEM001) TOGETHER. THE PHYSICIAN MANAGED TO GRAB THE RIGHT VENTRICLE LEAD USING THE NEEDLE'S EYE FEMORAL SNARE (LR-NES-001) AND PULL IT DOWNWARD. THEY WERE THEN ABLE TO RETRIEVE THE STUCK PHILIPS GLIDE LIGHT 14FR. THE PHYSICIAN CHANGED FROM A PHILIPS GLIDE LIGHT 14FR TO A PHILIPS GLIDE LIGHT 16FR. WITH THE PHILIPS GLIDE LIGHT 16FR, THE PHYSICIAN ATTEMPTED TO DETACH THE ADHESION, BUT THERE WAS A "LONG ADHESION OR TISSUE" ON THE LEAD TIP, WHICH THE PHILIPS GLIDE LIGHT 16FR COULD NOT BURN OFF. THE LASER WAS IRRADIATED AROUND 10 TIMES AT THE TIP OF THE LEAD. IT WAS CONFIRMED BY FLUOROSCOPY THAT THE TIP OF THE LEAD WAS IN THE SHEATH OF THE GLIDE LIGHT, BUT THE PHYSICIAN WAS UNABLE TO PULL THE LEAD OUT; HE ASSUMED THAT THERE WAS TISSUE ATTACHED TO THE LEAD TIP. THEY GRABBING THE TISSUE ATTACHED TO THE LEAD TIP USING THE REPORTED NEEDLE'S EYE FEMORAL SNARE (LR-NES001) AND SIMULTANEOUSLY IRRADIATED THE TISSUE WITH THE LASER AT THE SUPERIOR APPROACH. THE LEAD TIP CAME OUT HOWEVER, THE PHYSICIAN OBSERVED THE PATIENT AFTER THE LEAD WAS REMOVED, ANTICIPATING A POSSIBILITY OF CARDIAC TAMPONADE. THEY CONFIRMED PERICARDIAL EFFUSION. SOON AFTER THAT, THE PHYSICIAN PERFORMED PERICARDIOCENTESIS AND DRAINAGE OF THE PERICARDIAL EFFUSION. HOWEVER, PATIENT¿S BLOOD PRESSURE DIDN'T IMPROVE, NECESSITATING THORACOTOMY. CONSEQUENTLY, A LACERATION OF THE RIGHT VENTRICULAR APEX WAS FOUND, AND THE BLEEDING SITE WAS TREATED. THE PATIENT HAS REPORTEDLY RECOVERED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257442 LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION DXE CATHETER, EMBOLECTOMY DXE COOK VANDERGRIFT INC N163561 10827002265179

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention