BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2853210 · Received November 30, 2012

    Report

    Report Number
    3005099803-2012-05627
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE WAS NOT PROVIDED, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. (B)(4) FOR THE REPORTED ISSUE OF STENT POSITIONING PROBLEM. THE DEVICE WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. STENT MISPLACEMENT IS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THIS DEVICE, AND IS LISTED IN THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED WITHIN THE COLON OF A PATIENT ON (B)(6) 2012 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A MALIGNANT COLONIC OBSTRUCTION. DURING THE PROCEDURE, A WALLFLEX ENTERAL COLONIC STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE TARGET LESION; HOWEVER, THE STENT WAS INADVERTENTLY POSITIONED TOO PROXIMAL. REPORTEDLY, THE STENT WAS PLACED ABOVE THE TUMOR INSTEAD OF OVER THE TUMOR. NO ISSUES WERE ENCOUNTERED DURING DEPLOYMENT TO CAUSE THIS EVENT. THE STENT REMAINS IMPLANTED WITHIN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565060 15530354

    Patients

    Seq Age Sex Outcome Treatment
    1