BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 2862412 · Received December 10, 2012

    Report

    Report Number
    3005099803-2012-05777
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS OPERATIONAL CONTEXT; ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE MAY HAVE HINDERED THE DEVICE'S PERFORMANCE. 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 USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT A 3-4 CM MALIGNANT STRICTURE. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. THE LESION WAS NOT DILATED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE WITH THIS DEVICE, THE PHYSICIAN FELT THAT THE STENT WAS TOO LONG FOR THE STRICTURE AFTER IT WAS PARTIALLY DEPLOYED BY 75-80%. THE STENT WAS UNABLE TO BE FULLY RECONSTRAINED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SHORTER WALLFLEX BILIARY (10X40) 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
    1 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570530 0015018982

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR