BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1891242 · Received November 4, 2010

    Report

    Report Number
    3005099803-2010-04660
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR DEPLOYMENT SUTURE BREAK. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE STENT PARTIALLY DEPLOYED BY APPROXIMATELY 4MM. A VISUAL EXAMINATION OF THE DELIVERY SYSTEM FOUND NO KINKS OR BENDS. ADDITIONALLY, THE DEPLOYMENT SUTURE WAS EXAMINED AND THERE WAS NO EVIDENCE OF A BREAK. THE DEPLOYMENT SUTURE WAS PULLED AND THE STENT DEPLOYED WITHOUT ANY RESTRICTIONS. NO ISSUES WERE NOTED WITH THE STENT'S PROFILE. ALTHOUGH THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE REPORTED ISSUE OF DEPLOYMENT SUTURE BREAK, THE DEVICE WAS RETURNED PARTIALLY DEPLOYED, WHICH IS STILL CONSIDERED A REPORTABLE EVENT. THE MOST PROBABLE ROOT CAUSE IS BEING LABELED AS 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 UNCOVERED TRACHEOBRONCHIAL STENT WAS USED DURING A BRONCHOSCOPY PROCEDURE WITHIN THE BRONCHUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONCE THE PHYSICIAN BEGAN PULLING ON THE DEPLOYMENT SUTURE, IT BROKE. IT WAS REPORTED THAT THE STENT HAD NOT BEEN DEPLOYED AT ALL. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE WITHOUT ISSUE AND USE 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 WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX UNCOVERED TRACHEOBRONCHIAL STENT WAS USED DURING A BRONCHOSCOPY PROCEDURE WITHIN THE BRONCHUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONCE THE PHYSICIAN BEGAN PULLING ON THE DEPLOYMENT SUTURE, IT BROKE. IT WAS REPORTED THAT THE STENT HAD NOT BEEN DEPLOYED AT ALL. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE WITHOUT ISSUE AND USE 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 WELL.

    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 M00564510 13790200

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR