BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PRO

    MDR report key: 22869946 · Received August 22, 2025

    Report

    Report Number
    3005099803-2025-04104
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 29, 2025
    Report Date
    September 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729797524
    PMA / PMN Number
    K112994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE.

    Additional Manufacturer Narrative · 0

    BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON AUGUST 25, 2025. BLOCK H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON DID NOT DEFLATE WELL. IT WAS ALSO REPORTED THAT THEY WERE UNABLE TO RETRIEVE THE BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON DID NOT DEFLATE WELL. IT WAS ALSO REPORTED THAT THEY WERE UNABLE TO RETRIEVE THE BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 25, 2025: IT WAS REPORTED THAT THE TYPE OF PROCEDURE BEING PERFORMED WAS ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661267 CRE PRO BALLOON DILATOR FGE BOSTON SCIENTIFIC CORPORATION M00558640 0036060692 08714729797524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown