BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? DUODENAL

    MDR report key: 3193388 · Received June 27, 2013

    Report

    Report Number
    3005099803-2013-05802
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WITH DUODENAL STENT PLACEMENT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS A DOUDENAL STRICTURE DUE TO PANCREATIC CANCER. THE PATIENT'S ANATOMY WAS REPORTED TO BE NORMAL AND NOT PARTICULARLY TORTUOUS. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE DUODENUM AND THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE STENT WAS PARTIALLY DEPLOYED WHEN THE DEPLOYMENT HUB DETACHED FROM THE CATHETER AND THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT. 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 ¿OKAY¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292187 WALLFLEX? DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565030 0016024668

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR