BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PULMONARY

    MDR report key: 22003863 · Received May 12, 2025

    Report

    Report Number
    3005099803-2025-02132
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    February 11, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KTI
    UDI-DI
    08714729456223
    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 E1: INITIAL REPORTERS FACILITY NAME IS THE FIRST AFFILIATED (B)(6); REPORTED HERE AS THE FACILITY NAME EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. 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. BLOCK H11: INVESTIGATION RESULTS THE RETURNED CRE PULMONARY DILATATION BALLOON WAS ANALYZED AND A VISUAL INSPECTION FOUND NO PHYSICAL DAMAGE. A FUNCTIONAL EVALUATION FOUND THE BALLOON INFLATED WITHOUT PROBLEMS BUT WAS NOT ABLE TO HOLD PRESSURE DUE TO A PINHOLE IN THE BALLOON. MICROSCOPIC EVALUATION FOUND THE BALLOON HAD A PINHOLE LOCATED APPROXIMATELY 36MM FROM THE TIP OF THE DEVICE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES THE REPORTED EVENT OF BALLOON BURST WAS NOT CONFIRMED. THE RETURNED DEVICE WAS INFLATED WITHOUT ANY PROBLEM HOWEVER IT WAS NOT ABLE TO HOLD PRESSURE DUE TO A PINHOLE LOCATED APPROXIMATELY 36MM FROM THE TIP OF THE DEVICE. THE PINHOLE PROBLEM FOUND COULD HAVE BEEN INTERPRETED BY THE CUSTOMER AS THE REPORTED EVENT OF BALLOON BURST. IT IS POSSIBLE THAT THE PINHOLE FOUND ON THE BALLOON OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS EXCESS PRESSURE OR INTERACTION WITH OTHER DEVICES, OR ANATOMICAL FACTORS. ALSO, IT IS POSSIBLE THAT INTERACTION WITH A SHARP SURFACE DURING OR PREVIOUS TO THE PROCEDURE COULD HAVE CAUSED THE BALLOON PINHOLE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTERS FACILITY NAME IS (B)(6) HOSPITAL; REPORTED HERE AS THE FACILITY NAME EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. 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 ATTEMPTED TO BE USED IN THE SUBGLOTTIC AIRWAY DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED TO THE SUBGLOTTIC TRACHEA STENOSIS SITE, AND THE DILATATION WAS INEFFECTIVE AFTER BEING FILLED WITH WATER, RESULTING IN DILATATION FAILURE. IT WAS REPORTED THE BALLOON WAS FRACTURED. 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 AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

    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 THE SUBGLOTTIC AIRWAY DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED TO THE SUBGLOTTIC TRACHEA STENOSIS SITE, AND THE DILATATION WAS INEFFECTIVE AFTER BEING FILLED WITH WATER, RESULTING IN DILATATION FAILURE. IT WAS REPORTED THE BALLOON WAS FRACTURED. 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 AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016950 CRE PULMONARY BRONCHOSCOPE ACCESSORY KTI BOSTON SCIENTIFIC CORPORATION M00550340 0034265410 08714729456223

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female