BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1870379 · Received October 15, 2010

    Report

    Report Number
    3005099803-2010-04338
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MEDICAL INTERVENTION REQUIRED. (B)(4) - THE REPORTED ISSUE OF STENT POSITIONING PROBLEM. (B)(4) - THE REPORTED ISSUE OF STENT INCORRECTLY/MISASSEMBLED. (B)(4) - THE REPORTED ISSUE OF CUSTOMER ALTERED STENT. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, FOLLOWING A FULL REVIEW OF THE RELEVANT DEVICE SPECIFICATIONS, NO ISSUES OR ANOMALIES WERE NOTED WITH THIS PARTICULAR BATCH OF DEVICES. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. FROM THE INFORMATION AVAILABLE THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE DFU GIVES A WARNING TO ''VISUALLY INSPECT THE SYSTEM FOR ANY SIGN OF DAMAGE. DO NOT USE IF THE SYSTEM HAS ANY VISIBLE SIGNS OF DAMAGE. FAILURE TO OBSERVE THIS PRECAUTION MAY RESULT IN PATIENT INJURY.'' BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE IS USE/ USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS USED DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT WAS A MALIGNANCY. DURING THE PROCEDURE, THE STENT WAS REMOVED FROM THE PACKAGING, BUT UPON INSPECTION, IT WAS DISCOVERED THAT THE STENT WAS NOT LOCATED AT THE DISTAL END OF THE DELIVERY SHAFT. INSTEAD, THE STENT WAS PUSHED UP APPROXIMATELY 2 INCHES FROM THE END OF THE DELIVERY SHAFT. NO VISIBLE DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE PHYSICIAN ATTEMPTED TO BACKLOAD THE STENT SYSTEM OVER A GUIDE WIRE; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE STENT SYSTEM COULD NOT BE ADVANCED OVER THE WIRE. THE PHYSICIAN CUT OFF THE TIP OF THE DELIVERY SHAFT UP TO THE STENT. THE STENT SYSTEM WAS THEN BACK LOADED OVER THE GUIDE WIRE AND THE STENT WAS DEPLOYED WITHIN THE RIGHT MAIN STEM BRONCHUS. HOWEVER, THE STENT WAS DEPLOYED TOO PROXIMAL. THE PHYSICIAN USED BIOPSY FORCEPS TO REMOVE THE STENT FROM THE PATIENT. ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT OF THE SAME SIZE WAS UNAVAILABLE, THEREFORE, THE PROCEDURE WAS ABORTED. THE PATIENT WAS RESCHEDULED FOR A SECOND PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS USED DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT WAS A MALIGNANCY. DURING THE PROCEDURE, THE STENT WAS REMOVED FROM THE PACKAGING, BUT UPON INSPECTION, IT WAS DISCOVERED THAT THE STENT WAS NOT LOCATED AT THE DISTAL END OF THE DELIVERY SHAFT. INSTEAD, THE STENT WAS PUSHED UP APPROXIMATELY 2 INCHES FROM THE END OF THE DELIVERY SHAFT. NO VISIBLE DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE PHYSICIAN ATTEMPTED TO BACKLOAD THE STENT SYSTEM OVER A GUIDE WIRE; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE STENT SYSTEM COULD NOT BE ADVANCED OVER THE WIRE. THE PHYSICIAN CUT OFF THE TIP OF THE DELIVERY SHAFT UP TO THE STENT. THE STENT SYSTEM WAS THEN BACK LOADED OVER THE GUIDE WIRE AND THE STENT WAS DEPLOYED WITHIN THE RIGHT MAIN STEM BRONCHUS. HOWEVER, THE STENT WAS DEPLOYED TOO PROXIMAL. THE PHYSICIAN USED BIOPSY FORCEPS TO REMOVE THE STENT FROM THE PATIENT. ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT OF THE SAME SIZE WAS UNAVAILABLE, THEREFORE THE PROCEDURE WAS ABORTED. THE PATIENT WAS RESCHEDULED FOR A SECOND PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE FINE. ON (B)(6), 2010 THE FOLLOWING INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC: IT WAS REPORTED THAT THEY DID NOT WANT TO USE THE STENT BECAUSE THEY COULD NOT GET IT TO THE PROPER LOCATION, BUT THE PHYSICIAN OPTED TO CUT THE STENT TO TRY AND PLACE THE STENT, IN ORDER TO ELIMINATE HAVING THE PATIENT COME BACK. ACCORDING TO THE COMPLAINANT, FROM THE TIP OF THE CATHETER TO THE STENT, THERE WAS A TWO INCH GAP. THE STENT WAS LOADED TWO INCHES BACK ON THE CATHETER. THE STENT WAS UNABLE TO BE PLACED INTO THE PROPER LOCATION. THE PHYSICIAN THEN CUT THE TIP OFF OF THE DELIVERY CATHETER, AND THE STENT WAS DEPLOYED IN THE WRONG PLACE. IT IS UNKNOWN IF THE INCORRECT PLACEMENT WAS DUE TO THE CUTTING OF THE DEVICE OR JUST IMPROPER LOCATION.

    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 M00564830 0013621286

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention