BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMWIRE

    MDR report key: 2918539 · Received January 16, 2013

    Report

    Report Number
    3005099803-2013-00056
    Event Type
    Death
    Date Received
    January 16, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00198, AND 3005099803-2013-00056 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT SYSTEM AND A DREAMWIRE GUIDEWIRE WERE USED DURING A SIGMOID COLON STENTING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO DILATE A STRICTURE IN THE SIGMOID COLON DUE TO METASTATIC COLON CANCER. THE PATIENT HAD TWO LESIONS; ONE WAS 3-4 CM ON THE ANAL SIDE AND THE OTHER WAS 2-3 CM ON THE OTHER SIDE OF THE SIGMOID COLON. REPORTEDLY, THE PATIENT WAS TERMINALLY ILL AND IN BAD CONDITION. AS THE PATIENT WAS UNABLE TO UNDERGO SURGERY OR RADIATION THERAPY, STENT PLACEMENT WAS SELECTED. DURING THE PROCEDURE, THE STENT WAS ADVANCED OVER THE DREAMWIRE INTO THE TARGET ANATOMY. AFTER THE STENT PLACEMENT WAS COMPLETED, CARBON DIOXIDE AIR WAS SUPPLIED TO THE PATIENT AND THE STENT STARTED DILATING DUE TO NORMAL EXPANSION; HOWEVER, THE PATIENT SEEMED TO EXPERIENCE PAIN. NO TREATMENT WAS PROVIDED FOR THE PAIN. THE PHYSICIAN REPORTED THAT IT TOOK SOME MANEUVERING DURING STENT PLACEMENT AND IT IS A POSSIBILITY THAT THE EDGE OF THE STENT GOT STUCK IN THE TORTUOUS ANATOMY. THE PROCEDURE WAS COMPLETED USING THE SAME WALLFLEX ENTERAL COLONIC STENT SYSTEM AND DREAMWIRE GUIDEWIRE. ON (B)(6) 2012 A PERFORATION WAS CONFIRMED VIA CT SCAN AND THE INCREASING VALUE OF C-REACTIVE PROTEIN. AFTER FOLLOWING UP WITH THE PATIENT, THE CONDITION OF THE PATIENT TURNED WORSE AND THE PATIENT PASSED AWAY ON (B)(6) 2012. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS PERITONITIS DUE TO A PERFORATION. IN THE PHYSICIAN'S ASSESSMENT, IT IS POSSIBLE THAT THE PERFORATION MIGHT HAVE BEEN CAUSED BY THE STENT OR DURING MANIPULATIONS OF THE GUIDEWIRE. ADDITIONALLY, THE PHYSICIAN COMMENTED THAT SOME KIND OF TREATMENT SHOULD HAVE BEEN TAKEN WHEN THE PATIENT COMPLAINED OF PAIN. NO AUTOPSY REPORT IS AVAILABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00198, AND 3005099803-2013-00056 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT SYSTEM AND A DREAMWIRE GUIDEWIRE WERE USED DURING A SIGMOID COLON STENTING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO DILATE A STRICTURE IN THE SIGMOID COLON DUE TO METASTATIC COLON CANCER. THE PATIENT HAD TWO LESIONS; ONE WAS 3-4 CM ON THE ANAL SIDE AND THE OTHER WAS 2-3 CM ON THE OTHER SIDE OF THE SIGMOID COLON. REPORTEDLY, THE PATIENT WAS TERMINALLY ILL AND IN BAD CONDITION. AS THE PATIENT WAS UNABLE TO UNDERGO SURGERY OR RADIATION THERAPY, STENT PLACEMENT WAS SELECTED. DURING THE PROCEDURE, THE STENT WAS ADVANCED OVER THE DREAMWIRE INTO THE TARGET ANATOMY. AFTER THE STENT PLACEMENT WAS COMPLETED, CARBON DIOXIDE AIR WAS SUPPLIED TO THE PATIENT AND THE STENT STARTED DILATING DUE TO NORMAL EXPANSION; HOWEVER, THE PATIENT SEEMED TO EXPERIENCE PAIN. NO TREATMENT WAS PROVIDED FOR THE PAIN. THE PHYSICIAN REPORTED THAT IT TOOK SOME MANEUVERING DURING STENT PLACEMENT AND IT IS A POSSIBILITY THAT THE EDGE OF THE STENT GOT STUCK IN THE TORTUOUS ANATOMY. THE PROCEDURE WAS COMPLETED USING THE SAME WALLFLEX ENTERAL COLONIC STENT SYSTEM AND DREAMWIRE GUIDEWIRE. ON (B)(6) 2012 A PERFORATION WAS CONFIRMED VIA CT SCAN AND THE INCREASING VALUE OF C-REACTIVE PROTEIN. AFTER FOLLOWING UP WITH THE PATIENT, THE CONDITION OF THE PATIENT TURNED WORSE AND THE PATIENT PASSED AWAY ON (B)(6) 2012. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS PERITONITIS DUE TO A PERFORATION. IN THE PHYSICIAN'S ASSESSMENT, IT IS POSSIBLE THAT THE PERFORATION MIGHT HAVE BEEN CAUSED BY THE STENT OR DURING MANIPULATIONS OF THE GUIDEWIRE. ADDITIONALLY, THE PHYSICIAN COMMENTED THAT SOME KIND OF TREATMENT SHOULD HAVE BEEN TAKEN WHEN THE PATIENT COMPLAINED OF PAIN. NO AUTOPSY REPORT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24494 DREAMWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK578

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death