BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER, CATHETER

    MDR report key: 17490014 · Received August 9, 2023

    Report

    Report Number
    MW5122533
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Report Date
    March 31, 2023
    Manufacturer
    ABBOTT
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING PVI ABLATION AND UPON INSERTION OF RFN INTO ABBOTT'S SWARTZ SLO DURING BRK, A STRONG RESISTANCE WAS FELT, AND UPON REMOVAL, IT WAS SLIGHTLY BENT ON PROXIMAL SIDE FROM THE NEEDLE TIP, MAKING IT IMPOSSIBLE TO INSERT IT INTO SHEATH. A NEW NEEDLE WAS USED, INSERTED IN A SEPARATE SHEATH, AND BRK WAS PERFORMED BUT AFTER THAT A KINK OCCURRED, ALTHOUGH THERE WAS NO PROBLEM INSERTING AN ABLATION CATHETER OR OTHER DEVICE INTO THE SHEATH, A DEFECTIVE NEEDLE WAS REPORTED. (NOTE: SHEATH WAS KINKED AFTER SECOND NEEDLE INSERTION, FOR CLARIFICATION). 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
    2100539 INTRODUCER, CATHETER INTRODUCER, CATHETER DYB ABBOTT SWARTZ SLO SHEATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown