BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VHS

    MDR report key: 1599457 · Received February 16, 2010

    Report

    Report Number
    2242816-2010-00007
    Event Type
    Malfunction
    Date Received
    February 16, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 21, 2010
    Manufacturer
    EBI, LLC
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEWED AND NO ANOMALIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT METAL SHAVINGS WERE INSIDE THE LAG SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE IN THE LEFT MAIN STEM, PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN PULLED THE DEPLOYMENT SUTURE, IT "HUNG UP" AND THE STENT WOULD NOT FULLY DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX 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 "FINE". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VHS LAG SCREW, 60MM HSB EBI, LLC 701020

    Patients

    Seq Age Sex Outcome Treatment
    1