BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE WIREGUIDED

    MDR report key: 20895892 · Received December 10, 2024

    Report

    Report Number
    3005099803-2024-06211
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 1, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDF
    UDI-DI
    08714729339434
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: ADDITIONAL PRO CODE (PRODUCT CODE) ARE FDT AND KNQ; REPORTED HERE AS PRO CODE (PRODUCT CODE) EXCEEDED 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 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON BROKE AND LEAKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST A BALLOON BURST OCCURRED DURING 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
    2522842 CRE WIREGUIDED COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF BOSTON SCIENTIFIC CORPORATION M00558500 0034165662 08714729339434

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown