BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERNAL COLONIC STENT

    MDR report key: 1253114 · Received December 5, 2008

    Report

    Report Number
    3005099803-2008-06968
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 THAT DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE CATHETER REMOVAL DIFFICULTIES OCCURRED. A WALLFLEX ENTERAL COLONIC 27/22 X 6 230 CM HAD BEEN IMPLANTED TO TREAT AN UNSPECIFIED COLONIC LESION. DURING WITHDRAWAL, THE CATHETER "HUNG ON THE STENT". THE STENT "POPPED OUT OF THE STRICTURE". THE DELIVERY CATHETER WAS ABLE TO BE REMOVED. THE PHYSICIAN REMOVED THE STENT FROM THE RECTUM WITH HIS FINGER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERNAL COLONIC STENT MQR BOSTON SCIENTIFIC M00565100 0011367107

    Patients

    Seq Age Sex Outcome Treatment
    1 60+ Required Intervention