BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 6183206 · Received December 16, 2016

    Report

    Report Number
    3005099803-2016-03995
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 22, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K121048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN 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 ON (B)(6) 2016 THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS TO BE IMPLANTED AS PALLIATIVE TREATMENT FOR AN EXTERNAL STRICTURE CAUSED BY A TUMOR IN THE AIRWAYS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. THE PATIENT¿S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. REPORTEDLY, THE PATIENT HAD STAGE 4 LUNG CANCER AND RENAL FAILURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT. AFTER APPROXIMATELY ONE QUARTER OF THE STENT HAD DEPLOYED, THE DEPLOYMENT SUTURE WOULD NOT UNRAVEL AND THE CATHETER BOWED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT ON THE DELIVERY SYSTEM. THE COMPLAINANT REPORTED THAT THE STENT WAS ABLE TO BE DEPLOYED OUTSIDE THE PATIENT BY MANUALLY PULLING THE DEPLOYMENT SUTURE AT THE STENT. THE PROCEDURE WAS NOT COMPLETED. REPORTEDLY, THE PATIENT WAS INTUBATED AND THE PHYSICIAN PLANNED TO IMPLANT ANOTHER STENT THE NEXT DAY. HOWEVER, THE PHYSICIAN DECIDED NOT TO IMPLANT ANOTHER STENT DUE TO THE PATIENT EXPERIENCING SECONDARY COMPLICATIONS UNRELATED TO THE STENT OR STENT PLACEMENT PROCEDURE. REPORTEDLY, THE PATIENT HAD COMORBIDITIES THAT LEAD TO THE PATIENT¿S DEATH. ACCORDING TO THE COMPLAINANT, THE STENT PLACEMENT PROCEDURE WAS NOT RELATED TO THE PATIENT¿S COMPLICATIONS AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832955 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00576310 0019431761

    Patients

    Seq Age Sex Outcome Treatment
    1