BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PRO

    MDR report key: 17210753 · Received June 27, 2023

    Report

    Report Number
    3005099803-2023-03488
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 4, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729797531
    PMA / PMN Number
    K112994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: IMDRF CODE A041001 CAPTURES THE REPORTABLE EVENT OF BALLOON PINHOLE IN THE ESOPHAGUS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS NOT INFLATING PROPERLY. THE BALLOON WAS THEN TAKEN OUT OF THE PATIENT AND TESTED, A HOLE WAS DISCOVERED THAT PROJECTED WATER AND CONTRAST ACROSS THE ROOM. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477043 CRE PRO CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00558650 0026056263 08714729797531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown