BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERATOR LOCKING STYLET

    MDR report key: 19831208 · Received July 24, 2024

    Report

    Report Number
    MW5157616
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 9, 2024
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    DRB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE AN RA LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT IN THE PATIENT AS WELL BUT WAS NOT TARGETED FOR EXTRACTION. TO BEGIN THE PROCEDURE, A COOK MEDICAL LIBERATOR LOCKING STYLET WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH WAS USED TO AID IN LEAD REMOVAL, AND THE RA LEAD WAS SUCCESSFULLY EXTRACTED. HOWEVER, DURING RE-IMPLANTATION OF A NEW RA LEAD, A GRADUAL DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED, A PERICARDIAI EFFUSION WAS CONFIRMED WITH USE OF AN INTRACARDIAC ECHOCARDIOGRAPHY {ICE) CATHETER, AND A SLOW TAMPONADE WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING DRAINAGE TO RELIEVE THE TAMPONADE, BUT BLEEDING DID NOT STOP; THEREFORE, A THORACOTOMY FOLLOWED, AND AN RA PERFORATION WAS DISCOVERED AND REPAIRED. IT WAS SUSPECTED THAT THE PERFORATION WAS DUE TO TRACTION DURING EXTRACTION OF THE RA LEAD. THE PATIENT SURVIVED THE PROCEDURE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE LIBERATOR LOCKING STYLET. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933873 LIBERATOR LOCKING STYLET STYLET, CATHETER DRB COOK VANDERGRIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female SPECTRANETICS 14F GLIDELIGHT LASER SHEATH