BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURRICANE RX

    MDR report key: 23344658 · Received October 21, 2025

    Report

    Report Number
    3005099803-2025-05438
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    August 7, 2025
    Report Date
    March 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729283836
    PMA / PMN Number
    K130484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF BALLOON DAMAGED. BLOCK H11: INVESTIGATION RESULTS. THE RETURNED HURRICANE RX DILATATION BALLOON WAS ANALYZED, AND VISUAL INSPECTION FOUND THAT THE SHEATH WAS OBSERVED TO BE ACCORDIONED. FUNCTIONAL INSPECTION WAS PERFORMED, THE BALLOON WAS NOT CAPABLE OF BEING INFLATED AS THE LUMEN APPEARED TO BE OCCLUDED, MOST LIKELY BY DRIED CONTRAST MEDIA. THE DEVICE WAS SUBMERGED IN WARM WATER IN AN ATTEMPT TO REMOVE THE POSSIBLE CONTRAST MEDIA; HOWEVER, THE PROBLEM PERSISTED. X-RAY INSPECTION WAS ALSO PERFORMED; THE PRESENCE OF DRIED CONTRAST MEDIA WAS IDENTIFIED WITHIN THE CATHETER LUMEN. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON DAMAGED/DEFECTIVE WAS CONFIRMED. BASED ON THE VISUAL INSPECTION PERFORMED DURING DEVICE ANALYSIS, ACCORDIONING OF THE SHEATH WAS OBSERVED. THIS CONDITION IS TYPICALLY ASSOCIATED WITH EXCESSIVE COMPRESSIVE, OR ADVANCEMENT FORCES APPLIED TO THE DEVICE DURING PREPARATION, INSERTION, OR MANIPULATION THROUGH THE ENDOSCOPE OR ANATOMICAL PATHWAY. SUCH FORCES MAY CAUSE THE SHEATH MATERIAL TO BUCKLE AND FORM FOLDS CONSISTENT WITH AN ACCORDION-LIKE APPEARANCE. THEREFORE, THE OBSERVED SHEATH ACCORDIONING IS MOST LIKELY ATTRIBUTABLE TO PROCEDURAL OR HANDLING-RELATED FACTORS RATHER THAN A MANUFACTURING-RELATED ISSUE. FUNCTIONAL TESTING DETERMINED THAT THE BALLOON COULD NOT BE INFLATED DUE TO AN OCCLUSION WITHIN THE BALLOON LUMEN. X-RAY INSPECTION CONFIRMED THE PRESENCE OF DRIED CONTRAST MEDIA WITHIN THE LUMEN, WHICH LIKELY OBSTRUCTED THE INFLATION PATHWAY AND PREVENTED BALLOON EXPANSION. DESPITE ATTEMPTS TO CLEAR THE LUMEN BY SUBMERGING THE DEVICE IN WARM WATER, THE OCCLUSION PERSISTED. BASED ON THESE FINDINGS, THE REPORTED EVENT OF BALLOON LUMEN OCCLUDED/BLOCKED IS MOST LIKELY ATTRIBUTED TO DRIED CONTRAST MEDIA OBSTRUCTING THE BALLOON LUMEN, RESULTING IN THE INABILITY TO INFLATE THE BALLOON. DURING THE INVESTIGATION, NO EVIDENCE OF MANUFACTURING-RELATED DEFECTS WAS IDENTIFIED. THE INVESTIGATION FINDINGS AND ALL INFORMATION AVAILABLE CONCLUDES THE MOST PROBABLE ROOT CAUSE IS AN ADVERSE EVENT RELATED TO PROCEDURE. IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF BALLOON DAMAGED/DEFECTIVE AND BALLOON LUMEN OCCLUDED/BLOCKED WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF BALLOON DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BALLOON WAS ALREADY BROKEN BEFORE IT ENTERED THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BALLOON WAS ALREADY BROKEN BEFORE IT ENTERED THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285383 HURRICANE RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00545920 0034881542 08714729283836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown