BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX

    MDR report key: 1964519 · Received January 20, 2011

    Report

    Report Number
    3005099803-2011-00049
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    October 22, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE STENT PARTIALLY DEPLOYED BY ABOUT 14.5CM. THE DELIVERY SYSTEM WAS KINKED AT APPROXIMATELY 26CM PROXIMAL TO THE DISTAL TIP. THIS DAMAGE PROBABLY OCCURRED DURING THE ATTEMPTS TO DEPLOY THE STENT. WHEN THE DEPLOYMENT SUTURE WAS PULLED, THE STENT WAS DEPLOYED WITHOUT ISSUE. NO PROBLEMS OR ANOMALIES WERE NOTED WITH THE STENT'S PROFILE. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE REPORTED EVENT ISSUE OF A BENT DELIVERY SYSTEM; HOWEVER, THE STENT WAS RETURNED PARTIALLY DEPLOYED. 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 STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, THE PATIENT'S ANATOMY WAS PRE-DILATED TO 12MM WITH A BALLOON. AS THE STENT WAS BEING ADVANCED TO THE TARGET SITE, THE PHYSICIAN FELT SOME RESISTANCE, AND THE DELIVERY SYSTEM BECAME SLIGHTLY BENT. ONCE AT THE PROPER LOCATION, THE PHYSICIAN ATTEMPTED TO PULL ON THE DEPLOYMENT SUTURE; HOWEVER, THE STENT WOULD NOT DEPLOY. THE PHYSICIAN REMOVED THE DEVICE AND USED ANOTHER ULTRAFLEX 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 GOOD.THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS- THE STENT WAS RETURNED PARTIALLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00514150 13176495

    Patients

    Seq Age Sex Outcome Treatment
    1