BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PULMONARY

    MDR report key: 22637201 · Received July 28, 2025

    Report

    Report Number
    3005099803-2025-03506
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KTI
    UDI-DI
    08714729456216
    PMA / PMN Number
    K023337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: THE REMAINING PREMARKET/510(K) NUMBER IS K170759; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF A BALLOON PINHOLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING A BRONCHOSCOPY WITH TRACHEAL DILATION PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN USING THE DILATION BALLOON, THERE IS A MICRO-LEAK AT THE TIP, CAUSING IT TO DEFLATE. THE HOLE IS NOT VISIBLE BUT BECOMES EVIDENT WHEN INFLATED BECAUSE THE TIP LEAKS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO WAS PROVIDED BY THE CUSTOMER AND SHOWED THE TIP WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774002 CRE PULMONARY BRONCHOSCOPE ACCESSORY KTI BOSTON SCIENTIFIC CORPORATION M00550330 0034819914 08714729456216

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female