BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE WIREGUIDED

    MDR report key: 18818665 · Received March 1, 2024

    Report

    Report Number
    3005099803-2024-00799
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 9, 2024
    Report Date
    April 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729339427
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF BALLOON TIP BENT.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF BALLOON TIP BENT. BLOCK H10: INVESTIGATION RESULTS THE RETURNED CRE WIREGUIDED DILATATION BALLOON WAS ANALYZED, AND A VISUAL AND MEDIA INSPECTION FOUND THAT THE TIP OF THE GUIDEWIRE WAS BENT. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON TIP BENT WAS CONFIRMED. THE RESULTS OF THE ANALYSIS PERFORMED ON THE RETURNED DEVICE FOUND THAT THE TIP OF THE GUIDEWIRE WAS BENT. THE TIP BENT FOUND IS LIKELY TO HAVE OCCURRED DUE TO AN EXCESSIVE MANIPULATION OF THE DEVICE WITHOUT ENOUGH CARE DURING UNPACKING OF THE DEVICE. 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 USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE TIP OF THE BALLOON CATHETER WAS BENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. 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 WIREGUIDED DILATATION BALLOON WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE TIP OF THE BALLOON CATHETER WAS BENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297993 CRE WIREGUIDED DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00558490 0030404909 08714729339427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male