BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE WIREGUIDED

    MDR report key: 22101751 · Received May 28, 2025

    Report

    Report Number
    3005099803-2025-02301
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDF
    UDI-DI
    08714729339434
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    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 A041001 CAPTURES THE REPORTABLE EVENT OF A BALLOON PINHOLE IN THE ESOPHAGUS.

    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 ESOPHAGUS DURING A DILATION PROCEDURE TO TREAT ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE THE TECHNICIAN WAS INFLATING THE BALLOON TO 18 MM WITH WATER, IT WAS NOTED THAT THE BALLOON WAS LEAKING IN THE ENDOSCOPIC VIEW DUE TO A HOLE IN THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT, AND ANOTHER CRE WIREGUIDED DILATATION BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672934 CRE WIREGUIDED COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF BOSTON SCIENTIFIC CORPORATION M00558500 0035435734 08714729339434

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown