BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE FIXED WIRE

    MDR report key: 22117825 · Received May 30, 2025

    Report

    Report Number
    3005099803-2025-02458
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    UDI-DI
    08714729195993
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    BLOCK H2 (ADDITIONAL INFORMATION): BLOCK E1 (INITIAL REPORTER) HAS BEEN UPDATED. 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 DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER ATTEMPTING TO DEFLATE THE BALLOON, THEY WERE UNABLE TO ACHIEVE COMPLETE DEFLATION. AS A RESULT, THEY WITHDREW THE SCOPE WHILE THE BALLOON REMAINED PARTIALLY INFLATED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER ATTEMPTING TO DEFLATE THE BALLOON, THEY WERE UNABLE TO ACHIEVE COMPLETE DEFLATION. AS A RESULT, THEY WITHDREW THE SCOPE WHILE THE BALLOON REMAINED PARTIALLY INFLATED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26657 CRE FIXED WIRE DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC CORPORATION M00558370 0035954935 08714729195993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown