BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE WIREGUIDED

    MDR report key: 22709487 · Received August 4, 2025

    Report

    Report Number
    3005099803-2025-03747
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDF
    UDI-DI
    08714729339335
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: THE REMAINING PRO CODES (PRODUCT CODES) ARE FDT AND KNQ; REPORTED HERE AS PRO CODES (PRODUCT CODES) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF BALLOON DAMAGE.

    Additional Manufacturer Narrative · 0

    BLOCK H2 (ADDITIONAL INFORMATION): BLOCK A1 (PATIENT IDENTIFIER), B5 (DESCRIBE EVENT OR PROBLEM), AND H6 (DEIVCE CODES) HAVE BEEN UPDATED. BLOCK D2B: THE REMAINING PRO CODES (PRODUCT CODES) ARE FDT AND KNQ; REPORTED HERE AS PRO CODES (PRODUCT CODES) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF BALLOON DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE DILATATION BALLOON WAS USED TO DILATE THE STRICTURE OF THE COMMON BILE DUCT, THE BALLOON LEAKED GAS WITHOUT PRESSURIZATION, AND THE BALLOON WAS DAMAGED AFTER EXAMINATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE DILATATION BALLOON WAS USED TO DILATE THE STRICTURE OF THE COMMON BILE DUCT, THE BALLOON LEAKED GAS WITHOUT PRESSURIZATION, AND THE BALLOON WAS DAMAGED AFTER EXAMINATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ***ADDITIONAL INFORMATION RECEIVED AUGUST 5, 2025*** WHEN USING AN EXPANDING BALLOON TO DILATE THE STENOSIS PART OF THE COMMON BILE DUCT, THE BALLOON BEGAN TO LEAK BEFORE ANY PRESSURE WAS APPLIED. IT WAS FOUND THAT THE BALLOON HAD ALREADY BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277498 CRE WIREGUIDED COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF BOSTON SCIENTIFIC CORPORATION M00558400 0034782813 08714729339335

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female