BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PRO

    MDR report key: 20118168 · Received September 2, 2024

    Report

    Report Number
    3005099803-2024-04151
    Event Type
    Malfunction
    Date Received
    September 2, 2024
    Date of Event
    July 17, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729797494
    PMA / PMN Number
    K112994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTER FACILITY NAME: THE FIFTH AFFILIATED HOSPITAL OF SOUTHERN MEDICAL UNIVERSITY; REPORTED HERE AS INITIAL REPORTER FACILITY NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST.

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6)HOSPITAL. 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 PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY DUCT DURING A BILIARY DUCT DILATION UNDER ENDOSCOPE AND BILIARY CALCULI REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WAS PLACED FOR DILATION. IT WAS FOUND THAT THE BALLOON BURST WHEN IT WAS INFLATED TO 3 ATM AND LEAKED CONTRAST. IT WAS REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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 CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY DUCT DURING A BILIARY DUCT DILATION UNDER ENDOSCOPE AND BILIARY CALCULI REMOVAL PROCEDURE PERFORMED ON (B)(6)2024. DURING THE PROCEDURE, THE BALLOON WAS PLACED FOR DILATION. IT WAS FOUND THAT THE BALLOON BURST WHEN IT WAS BEING INFLATED TO AROUND 3 ATM AND LEAKING CONTRAST. IT WAS REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873683 CRE PRO CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00558610 0032919753 08714729797494

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female