BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3151787 · Received June 7, 2013

    Report

    Report Number
    3005099803-2013-05125
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS RETURNED WITH THE DISTAL END PARTIALLY DEPLOYED BY APPROXIMATELY 140 MM. DURING ANALYSIS, IT WAS POSSIBLE TO RETRACT THE REMAINDER OF THE DEPLOYMENT SUTURE AND DEPLOY THE STENT WITHOUT ISSUE. NO OTHER ISSUES WERE NOTED TO THE DEVICE. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT. THIS IS DEFINED AS A COMPLAINT THAT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE ESOPHAGUS OF A PATIENT ON (B)(6) 2013 DURING A STENT INSERTION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING IMPLANTED DUE TO A MALIGNANCY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, AND HAD BEEN DILATED PRIOR TO THE STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS IN POSITION AND ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT WAS NOT ABLE TO BE RELEASED. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO PLACE A STENT AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE ESOPHAGUS OF A PATIENT ON (B)(6) 2013 DURING A STENT INSERTION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING IMPLANTED DUE TO A MALIGNANCY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, AND HAD BEEN DILATED PRIOR TO THE STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS IN POSITION AND ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT WAS NOT ABLE TO BE RELEASED. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO PLACE A STENT AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS 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
    253225 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513750 15539920

    Patients

    Seq Age Sex Outcome Treatment
    1