BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2251773 · Received September 16, 2011

    Report

    Report Number
    3005099803-2011-03207
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS NOT COMPLETED AS THE DILATION WAS NOT DEEMED NECESSARY.

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4): FOR THE REPORTED EVENT OF BALLOON PINHOLE. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES WITH THE CATHETER OF THE DEVICE. HOWEVER, THROUGH FUNCTIONAL TESTING TWO PINHOLES WERE NOTED TO THE BALLOON MATERIAL. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED EVENTS OF BALLOON LEAK AND INFLATION DIFFICULTY WERE CONFIRMED, AS PINHOLES WERE FOUND IN THE BALLOON MATERIAL. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE PAPILLA PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED AND CONTRAST WAS LEAKING OUT OF THE BALLOON. THROUGH INVESTIGATION RESULTS, A PINHOLE WAS NOTED TO THE BALLOON MATERIAL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE PAPILLA PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED AND CONTRAST WAS LEAKING OUT OF THE BALLOON. THROUGH INVESTIGATION RESULTS, A PINHOLE WAS NOTED TO THE BALLOON MATERIAL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE¿ WIREGUIDED ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558460 14077082

    Patients

    Seq Age Sex Outcome Treatment
    1