BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER, CATHETER

    MDR report key: 17527243 · Received August 12, 2023

    Report

    Report Number
    MW5134177
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    January 9, 2018
    Report Date
    February 1, 2018
    Manufacturer
    TERUMO
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED AT THE BEGINNING A RIGHT-SIDED ATRIAL FLUTTER CASE, AN AIR EMBOLISM WAS NOTICED. CALLER REPORTED THE PHYSICIAN SAW THE EMBOLISM ON FLUOROSCOPY. CALLER REPORTED THAT NO MEDICAL INTERVENTION WAS NEEDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED STATED THAT PRIOR TO THE USE OF THE BIOSENSE WEBSTER, INC. PRODUCTS, AN AIR EMBOLISM WAS DETECTED VIA FLUOROSCOPY. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT THE SHEATH THAT WAS GIVEN TO HIM WAS DIFFERENT THAN THE ONE HE EXPECTED. (B)(4). 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
    764294 INTRODUCER, CATHETER INTRODUCER, CATHETER DYB TERUMO

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown