BEUDAMED
    FDA Adverse Event Other Summary report: N

    360 EXPRESS BALLOON CATHETER

    MDR report key: 20461454 · Received October 15, 2024

    Report

    Report Number
    MW5161064
    Event Type
    Other
    Date Received
    October 15, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 10, 2024
    Manufacturer
    COVIDIEN LLC.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT SCHEDULE FOR EGD(ESOPHAGOGASTRODUODENOSCOPY) WITH HALO. DR REQUESTED 360 HALO CATHETER. HALO 360 BALLOON WOULD NOT INFLATE. ALL CONNECTIONS CHECKED AND DISCONNECTED/RECONNECTED, BUT BALLOON STILL WOULD NOT INFLATE. SECOND HALO 360 CATHETER OPENED FOR PROCEDURE AND AGAIN BALLOON WOULD NOT INFLATE. DURING THIS TIME PT WAS INTUBATED AND SEDATED AND EGD SCOPE WAS IN PT ESOPHAGUS WHILE WAITING FOR HALO CATHETER TO INFLATE. REP FOR MEDTRONIC WAS CALLED DURING THE PROCEDURE TO ASK IF HE HAD ANY TROUBLE SHOOTING IDEAS, BUT WE HAD ALREADY DONE THE ONES HE RECOMMENDATION WITHOUT SUCCESS. REF REPORT: MW5161065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367840 360 EXPRESS BALLOON CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LLC. 64082 B000002827

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male