BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT SL1 SHEATH

    MDR report key: 21559147 · Received March 10, 2025

    Report

    Report Number
    MW5167431
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 7, 2025
    Report Date
    March 6, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6). NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6). PRODUCT. IT WAS REPORTED THAT A PERFORATION LEADING TO A PERICARDIAL EFFUSION OCCURRED DURING THE PROCEDURE. THE PHYSICIAN NOTICED THE PATIENT'S ARTERIAL PRESSURE HAD DROPPED IN THE MIDDLE OF THE CASE JUST AFTER THE SECOND TRANSSEPTAL. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PROCEDURE WAS ABORTED. NO ABLATION HAD BEEN PERFORMED YET. A PERICARDIAL WINDOW WAS PERFORMED AS THE MEDICAL INTERVENTION. THE PATIENT'S LAST KNOWN STATUS WAS STABLE AND IN THE INTENSIVE CARE UNIT (ICU). THE FOLLOWING THERAPEUTIC/DIAGNOSTIC BWI PRODUCTS WERE IN USE: DECANAV CATHETER (R7F282CT / AD24380046) AND SOUNDSTAR ICE CATHETER STERILMED (R10439011 / 2222835). ADDITIONAL INFORMATION WAS RECEIVED STATING SL1 AND SL2 SHEATHS WERE USED FOR THE TRANSSEPTAL PUNCTURE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5167432.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338647 ABBOTT SL1 SHEATH INTRODUCER, CATHETER DYB ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DECANAV CATHETER (R7F282CT /AD24380046) | SOUNDSTAR ICE CATHETER STERILMED (R10439011 / 2222835).