BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX NON-COVERED ESOPHAGEAL STENT

    MDR report key: 1193267 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05107
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT DEPLOY. THE PROCEDURE HAD BEEN POSTPONED FOR A WEEK FOR UNSPECIFIED REASONS. THE VERY TORTUOUS TARGET LESION WAS IN THE ESOPHAGUS. THE PHYSICIAN ENCOUNTERED DIFFICULTY IN ADVANCING AN UNSPECIFIED TYPE OF 0.035 INCH GUIDE WIRE THROUGH THE STOMACH DUE TO THE STOMACH'S UNSPECIFIED "DEFORMATION". THE PHYSICIAN DILATED AN UNSPECIFIED ESOPHAGEAL STRICTURE WITH AN UNSPECIFIED BALLOON AND THE GUIDE WIRE WAS ABLE TO BE ADVANCED TO THE DUODENUM WITH AN UNSPECIFIED TYPE OF SCOPE. THE PHYSICIAN FOUND IT "VERY DIFFICULT" TO ADVANCE THE SCOPE INTO THE DUODENUM. A ESOPHAGEAL STENT HAD BEEN ADVANCED TO THE TARGET LESION; HOWEVER, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN PULLING THE SUTURE AND DEPLOYING THE STENT. THE PHYSICIAN REPOSITIONED THE STENT AND MADE A SECOND ATTEMPT TO DEPLOY THE STENT, WHICH WAS ALSO UNSUCCESSFUL. THE PROCEDURE HAD TAKEN LONGER THAN THE PHYSICIAN INTENDED, SO THE PHYSICIAN REMOVED THE WHOLE SYSTEM FROM THE PATIENT AND THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX NON-COVERED ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC M00513030

    Patients

    Seq Age Sex Outcome Treatment
    1