BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1854579 · Received October 5, 2010

    Report

    Report Number
    3005099803-2010-04187
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO BE (B)(6). (B)(4). AN EXAMINATION OF THE RETURNED ULTRAFLEX STENT FOUND THAT THE DISTAL LOOPS OF THE STENT HAD BEEN DEPLOYED, AND THE DELIVERY SYSTEM WAS BENT JUST PROXIMAL TO THE STENT. ADDITIONALLY, THE DEPLOYMENT SUTURE WAS CAUGHT ON THE DISTAL STENT LOOPS, WHICH PREVENTED DEPLOYMENT. ONCE THE THREAD WAS DISENTANGLED FROM THE STENT LOOPS, THE STENT COULD BE DEPLOYED WITHOUT ISSUE. NO ANOMALIES WERE NOTED WITH THE PROFILE OF THE DEVICE. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS OPERATIONAL CONTEXT. 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 ESOPHAGEAL COVERED STENT WAS USED DURING A TRACHEAL ENDOSCOPY PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A 20MM LESION OF THE RIGHT MAIN BRONCHUS AS A RESULT OF TRACHEAL CANCER. THE PHYSICIAN DID NOT PREDILATE THE LESION PRIOR TO PERFORMING THIS PROCEDURE. AS THE COMPLAINANT ATTEMPTED TO DEPLOY THE STENT AT THE TARGET SITE, SIGNIFICANT RESISTANCE WAS FELT; WHEN EXTRA FORCE WAS APPLIED TO THE DEPLOYMENT SUTURE, THE CATHETER FOLDED BACKWARDS ON ITSELF. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THERE WAS NO EVIDENCE OF THE SUTURE BEING CAUGHT ON ANYTHING. THE COMPLAINANT NOTED THAT WHILE THE DEPLOYMENT SUTURE WAS LOOSE, IT WAS NOT BROKEN. ADDITIONALLY, THE STENT WAS NOT DEPLOYED FROM THE CATHETER. THE COMPLAINANT USED A SECOND ULTRAFLEX 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS- STENT WAS RETURNED PARTIALLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564800 0013143117

    Patients

    Seq Age Sex Outcome Treatment
    1