BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE FIXED WIRE

    MDR report key: 20685727 · Received November 14, 2024

    Report

    Report Number
    3005099803-2024-05729
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    UDI-DI
    08714729202011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN A PROCEDURE. THE EXACT PROCEDURE SATE IS UNKNOWN. IT WAS REPORTED THAT, THE BALLOON WOULD NOT DEFLATE IN ORDER TO REMOVE IT THROUGH THE ENDOSCOPE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204925 CRE FIXED WIRE DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC CORPORATION M00558380 0033783231 08714729202011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown