BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE WIREGUIDED

    MDR report key: 20698794 · Received November 15, 2024

    Report

    Report Number
    3005099803-2024-05744
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 21, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDF
    UDI-DI
    08714729339434
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL PRO CODES ARE FDT, KNQ; REPORTED HERE AS PRO CODE (PRODUCT CODE) EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST.

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL PRO CODES ARE FDT, KNQ; REPORTED HERE AS PRO CODE (PRODUCT CODE) EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST. BLOCK H11: INVESTIGATION RESULTS THE RETURNED CRE WIREGUIDED DILATATION BALLOON WAS ANALYZED, AND A VISUAL EVALUATION NOTED NO DAMAGES. FUNCTIONAL TESTING WAS PERFORMED WHERE IT WAS NOT ABLE TO HOLD PRESSURE DUE TO A PINHOLE IN THE BALLOON LOCATED APPROXIMATELY 68 MM FROM THE TIP OF THE DEVICE, WHICH WAS CONFIRMED DURING MICROSCOPIC INSPECTION. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES THE REPORTED EVENT OF BALLOON BURST WAS UNABLE TO BE CONFIRMED. THE RETURNED DEVICE WAS INSPECTED, AND FUNCTIONAL TESTING REVEALED A BALLOON PINHOLE LOCATED APPROXIMATELY 68 MM FROM THE DEVICE TIP. THE MOST PROBABLE CAUSE FOR THIS EVENT IS ADVERSE EVENT RELATED TO PROCEDURE. IT IS POSSIBLE THAT THE PINHOLE FOUND IN THE BALLOON OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS EXCESS PRESSURE, INTERACTION WITH OTHER DEVICES, OR ANATOMICAL CONDITIONS. ALSO, IT IS POSSIBLE THAT INTERACTION WITH A SHARP SURFACE DURING OR AFTER THE PROCEDURE COULD HAVE CAUSED THE PINHOLE ON THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS AN ADVERSE EVENT RELATED TO PROCEDURE.

    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 COLON DURING A STRICTURE DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE BALLOON, BUT THE BALLOON BURST IN THE MIDDLE. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 AFTER THE PROCEDURE WAS REPORTED TO BE OKAY.

    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 COLON DURING A STRICTURE DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE BALLOON, BUT THE BALLOON BURST IN THE MIDDLE. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 AFTER THE PROCEDURE WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74672 CRE WIREGUIDED COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF BOSTON SCIENTIFIC CORPORATION M00558500 0032937724 08714729339434

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown