BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATHETER

    MDR report key: 18885422 · Received March 8, 2024

    Report

    Report Number
    MW5152622
    Event Type
    Other
    Date Received
    March 8, 2024
    Report Date
    July 2, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY WERE EXPERIENCING DIFFICULTY ADVANCING THE VERSACROSS DILATOR OVER THE J-TIP GUIDEWIRE. THEY DECIDED TO SWAP OUT THE GUIDEWIRE FOR A STIFFER OPTION (NON-BSC, ABBOTT AMPLATZER .035 J-WIRE). THE DILATOR WAS THEN ABLE TO ADVANCE TO SVC(SUPERIOR VENA CAVA), BUT WHEN WITHDRAWING THE GUIDEWIRE, IT BECAME STUCK. THE DILATOR AND GUIDEWIRE WERE THEN REMOVED TOGETHER FROM THE PATIENT WHERE IT WAS NOTED THAT THE GUIDEWIRE WAS ALSO UNCOILING. 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
    181236 CATHETER CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL AMPLATZER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown