BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE? WIREGUIDED

    MDR report key: 3175743 · Received June 18, 2013

    Report

    Report Number
    3005099803-2013-05280
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. THE 510K NUMBER IS K112994. ACCORDING TO THE COMPLAINANT, THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE AN EVALUATION COULD NOT BE COMPLETED. 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 STONE REMOVAL PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN DILATED THE PAPILLARY AND THEN TRIED TO REMOVE THE DEVICE FROM THE ENDOSCOPE. HOWEVER, DUE TO SEVERE RESISTANCE IT COULD NOT BE REMOVED. THE PHYSICIAN ATTEMPTED TO REMOVE IT FORCIBLY, AND THE CATHETER BROKE. THE DISTAL PART WITH THE BALLOON REMAINED INSIDE THE SCOPE. IT WAS CONFIRMED THAT NO FRAGMENTS OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275057 CRE? WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558700 15344366

    Patients

    Seq Age Sex Outcome Treatment
    1