BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? TRACHEOBRONCHIAL

    MDR report key: 3952934 · Received July 23, 2014

    Report

    Report Number
    3005099803-2014-02580
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND OUT THAT THE STENT WAS RECEIVED PARTIALLY DEPLOYED BY 7 MM. THE INVESTIGATOR NOTED THAT BOTH SILASTIC BANDS WERE PRESENT AND IT WAS ALSO NOTED THAT THE PULLRING WAS FULLY ATTACHED THROUGH THE HUB. DURING THE PRODUCT ANALYSIS, THE INVESTIGATOR WAS ABLE TO DEPLOY THE STENT WITHOUT ISSUE. NO ISSUES WERE NOTED WITH THE PROFILE OF THE STENT. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE NOTED ISSUE WAS LIKELY DUE TO THE HANDLING OF THE DEVICE OR PORTION OF THE DEVICE WITHOUT DIRECT PATIENT CONTACT EITHER DURING UNPACKING, PREPARATION, OR SHIPPING; AT THE END OF THE PROCEDURE; OR WHEN PACKAGING FOR RETURN. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF STENT PARTIALLY DEPLOYED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A BRONCHOSCOPY PROCEDURE IN THE LUNGS PERFORMED ON (B)(6) 2014. REPORTEDLY, THE STRICTURE WAS TIGHT AND THE LUMEN WAS 5% OPEN. ACCORDING TO THE COMPLAINANT, OUTSIDE THE PATIENT, THE STENT WAS PARTIALLY DEPLOYED BY FEW MM. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. 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 ¿STABLE.¿

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A BRONCHOSCOPY PROCEDURE IN THE LUNGS PERFORMED ON (B)(6) 2014. REPORTEDLY, THE STRICTURE WAS TIGHT AND THE LUMEN WAS 5% OPEN. ACCORDING TO THE COMPLAINANT, OUTSIDE THE PATIENT, THE STENT WAS PARTIALLY DEPLOYED BY FEW MM. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. 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 ¿STABLE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429869 ULTRAFLEX? TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564860 0016554229

    Patients

    Seq Age Sex Outcome Treatment
    1