BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 3102875 · Received May 9, 2013

    Report

    Report Number
    3005099803-2013-03634
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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 BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WITH BILIARY STENT PLACEMENT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED BUT DID NOT REACH THE COMMON BILE DUCT, THE PHYSICIAN FELT THE STENT APPEARED SHORTER THAN IT SHOULD BE. THE PHYSICIAN NOTED THAT THE APPARENT LENGTH DISCREPANCY MAY HAVE BEEN DUE TO PATIENT ANATOMY. THE STENT WAS LEFT IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203765 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570640 15839311

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention