BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PULMONARY

    MDR report key: 22155639 · Received June 5, 2025

    Report

    Report Number
    3005099803-2025-02498
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 12, 2025
    Report Date
    June 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KTI
    UDI-DI
    08714729456216
    PMA / PMN Number
    K023337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 A0504 CAPTURES THE REPORTABLE EVENT OF A BALLOON LEAK.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN A PROCEDURE TO TREAT THE AIRWAY PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719516 CRE PULMONARY BRONCHOSCOPE ACCESSORY KTI BOSTON SCIENTIFIC CORPORATION M00550330 0035458514 08714729456216

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female