BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    MDR report key: 1931519 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05140
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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 AN ULTRAFLEX ESOPHAGEAL COVERED STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE UPPER ESOPHAGUS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER THE STENT HAD ALMOST BEEN COMPLETELY DEPLOYED, THE NURSE ENCOUNTERED RESISTANCE. WHEN THE PHYSICIAN WENT TO CHECK AND WITHDRAW THE DELIVERY SYSTEM, THE STENT WAS STILL ATTACHED. AFTER REMOVING THE DEVICE FROM THE PATIENT, THE PHYSICIAN NOTED THAT THERE WAS A SMALL KNOT IN THE DEPLOYMENT SUTURE, WHICH PROBABLY GOT TANGLED UP ON THE STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY THE FOLLOWING DAY WITH A WALLFLEX 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513850 12590909

    Patients

    Seq Age Sex Outcome Treatment
    1