BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HURRICANE RX

    MDR report key: 10321515 · Received July 24, 2020

    Report

    Report Number
    3005099803-2020-02895
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    June 1, 2020
    Report Date
    August 25, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K001338
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2020 AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE UPN AND LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H2: ADDITIONAL INFORMATION: BLOCK B5, D8, AND H10 BLOCK H6: PROBLEM CODE 2922 CAPTURES THE REPORTABLE EVENT OF BALLOON PROTECTIVE SLEEVE DETACHED. BLOCK H10: ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. CORRECTION: BLOCK H10

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, IT WAS NOTED THAT THE BALLOON PROTECTIVE SLEEVE WAS NOT VISIBLE UNDER DIMMED LIGHT. REPORTEDLY, THE NEW STAFF UNNOTICED THAT THE PROTECTIVE SLEEVE DEPLOYED INSIDE THE PATIENT BILE DUCT. THE PROTECTIVE SLEEVE WAS SUCCESSFULLY RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6)2020*** THE ANATOMY LOCATION WAS THE BILE DUCT, AND THE PROCEDURE WAS AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2020 AS NO EVENT DATE WAS REPORTED. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, IT WAS NOTED THAT THE BALLOON PROTECTIVE SLEEVE WAS NOT VISIBLE UNDER DIMMED LIGHT. REPORTEDLY, THE PROTECTIVE SLEEVE DEPLOYED INSIDE THE BILE DUCT OF THE PATIENT. THE PROTECTIVE SLEEVE WAS SUCCESSFULLY RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783663 HURRICANE RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention