BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE FIXED WIRE

    MDR report key: 22287546 · Received June 18, 2025

    Report

    Report Number
    3005099803-2025-02790
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H2 (ADDITIONAL INFORMATION): BLOCK B5 (DESCRIBE EVENT OR PROBLEM) HAS BEEN UPDATED. 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 DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO ALL 3 SIZES. WHEN ATTEMPTING TO DEFLATE THEY COULD NOT GET ALL OF THE WATER OUT OF THE BALLOON AND HAD TO REMOVE SCOPE WITH BALLOON STILL HANGING OUT OF THE SCOPE. A COUPLE OF CM STILL HAD FLUID IN THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JUNE 25, 2025. IT WAS REPORTED THAT THE ANATOMY LOCATION OF THE PROCEDURE WAS ESOPHAGUS.

    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 TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO ALL 3 SIZES. WHEN ATTEMPTING TO DEFLATE THEY COULD NOT GET ALL OF THE WATER OUT OF THE BALLOON AND HAD TO REMOVE SCOPE WITH BALLOON STILL HANGING OUT OF THE SCOPE. A COUPLE OF CM STILL HAD FLUID IN THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING 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
    1639967 CRE FIXED WIRE DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC CORPORATION M00558370 0035962106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown