BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 3110973 · Received May 14, 2013

    Report

    Report Number
    3005099803-2013-03810
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED ISSUE OF STENT PARTIALLY DEPLOYED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE COMMON BILE DUCT (CBD) OF A PATIENT ON (B)(6) 2013 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE OR PACKAGING PRIOR TO BEING USED. DURING THE PROCEDURE, APPROXIMATELY 75% OF THE STENT WAS DEPLOYED WITHIN THE PATIENT WHEN THE METAL SHAFT OF THE DEVICE BROKE INTO TWO PARTS. THE PHYSICIAN WAS ONLY ABLE TO RECONSTRAIN APPROXIMATELY 50% OF THE STENT PRIOR TO REMOVAL FROM THE PATIENT. IN ADDITION, IT WAS NOTED THAT THE OUTER SHEATH OF THE DEVICE APPEARED TO BE STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212076 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570540 15868515

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR