BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    MDR report key: 1843565 · Received September 24, 2010

    Report

    Report Number
    3005099803-2010-03992
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. 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 NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX COVERED ESOPHAGEAL STENT WAS USED DURING A PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO DEPLOY THE STENT, THE DEPLOYMENT SUTURE BROKE; THE STENT WAS PARTIALLY DEPLOYED. THERE WAS NO REPORTED RESISTANCE WHEN PULLING ON THE SUTURE, AND THE SUTURE WAS NOT CAUGHT ON ANYTHING. THERE WAS NO BOWING OF THE DELIVERY SYSTEM. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE WITH A BIOPSY GRIP AND USE ANOTHER ULTRAFLEX COVERED ESOPHAGEAL STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513860 13683432

    Patients

    Seq Age Sex Outcome Treatment
    1