BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE FIXED WIRE

    MDR report key: 23538802 · Received November 12, 2025

    Report

    Report Number
    3005099803-2025-06071
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    September 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    UDI-DI
    08714729195993
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H2: BLOCK G1 MFR SITE FACILITY NAME, MFR SITE ADDRESS 1, AND MFR SITE ADDRESS 2 HAVE BEEN CORRECTED. BLOCK H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE.

    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 THE ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON DID NOT FULLY DEFLATE AFTER DILATING THE ESOPHAGUS. THE CATHETER COULD NOT BE REMOVED SO THE SCOPE WAS WITHDRAWN FROM THE PATIENT, AND THE BALLOON END WAS CUT OFF TO BE REMOVED FROM THE SCOPE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 12, 2025. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON DID NOT FULLY DEFLATE AFTER DILATING THE ESOPHAGUS. THE CATHETER COULD NOT BE REMOVED SO THE SCOPE WAS WITHDRAWN FROM THE PATIENT, AND THE BALLOON END WAS CUT OFF TO BE REMOVED FROM THE SCOPE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119908 CRE FIXED WIRE DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC CORPORATION M00558370 0036853550 08714729195993

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male