BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE? WIREGUIDED

    MDR report key: 4222738 · Received November 4, 2014

    Report

    Report Number
    3005099803-2014-03564
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K112994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE FIRST PROCEDURE, THE WINGTOOL COVERING OF THE BALLOON WAS NOT REMOVED WHEN THEY TRIED TO ADVANCE THE BALLOON THROUGH THE SCOPE. THEY WERE FINALLY ABLE TO PUSH THE BALLOON TO THE END OF THE SCOPE AND THEN HAD DIFFICULTY INFLATING THE BALLOON. THE DEVICE AND THE SCOPE WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS FINISHED WITH A DIFFERENT SCOPE AND A NEW CRE BALLOON. THE FIRST SCOPE WAS CLEANED AND USED AGAIN FOR ANOTHER PROCEDURE THAT SAME DAY, IN A DIFFERENT PATIENT. REPORTEDLY, WHEN THEY INSERTED THE BIOPSY FORCEPS THROUGH THE SCOPE, THE WINGTOOL FROM THE PREVIOUS PROCEDURE WAS COMING OUT FROM THE SCOPE AND DETACHED INTO THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING A GRASPER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT FOR BOTH PATIENTS. THE SECOND PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708320 CRE? WIREGUIDED CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00558680 0015326359

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention