BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE WIREGUIDED

    MDR report key: 21976251 · Received May 7, 2025

    Report

    Report Number
    3005099803-2025-02036
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 17, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDF
    UDI-DI
    08714729339403
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: THE REMAINING PRO CODES (PRODUCT CODES) ARE FDT AND KNQ; REPORTED HERE AS PRO CODES (PRODUCT CODES) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512647 CRE WIREGUIDED COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF BOSTON SCIENTIFIC CORPORATION M00558470 0032127426 08714729339403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown