BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 3083393 · Received April 29, 2013

    Report

    Report Number
    3005099803-2013-03036
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    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 BILIARY (10X60) COVERED STENT WAS TO BE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT STRICTURE, APPROXIMATELY 4 CM IN SIZE.. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. THE LESION WAS NOT DILATED PRIOR TO THE PROCEDURE. DURING PREPARATION PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE DISTAL PART OF THE STENT AND CATHETER WERE KINKED. THEY PROCEEDED TO USE THE DEVICE FOR THE PROCEDURE. DURING THE PROCEDURE WHEN ATTEMPTING TO DEPLOY THE STENT, IT WAS UNABLE TO COMPLETELY DEPLOY. THE PARTIALLY DEPLOYED STENT WAS RECONSTRAINED AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY COVERED STENT 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185060 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570530 0015740711

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR