BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PULMONARY

    MDR report key: 21256504 · Received January 28, 2025

    Report

    Report Number
    3005099803-2025-00119
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    November 21, 2024
    Report Date
    January 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KTI
    UDI-DI
    08714729456223
    PMA / PMN Number
    K023337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: THIS EVENT WAS REPORTED BY THE DIRECTOR OF REGULATORY AFFAIRS. THE HEALTHCARE FACILITY WAS NOT REPORTED ON THE MEDWATCH FORM AND IS UNKNOWN. 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 A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON POPPED INSIDE THE PATIENT WHILE DILATING THE AIRWAY. THE BALLOON WAS FILLED WITH A 50/50 MIXTURE OF OMNIPAQUE 350 MGL/ML AND NORMAL SALINE. NO FURTHER EVENT INFORMATION WAS PROVIDED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549921 CRE PULMONARY BRONCHOSCOPE ACCESSORY KTI BOSTON SCIENTIFIC CORPORATION M00550340 0033118849 08714729456223

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male