BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMWIRE¿

    MDR report key: 2180118 · Received July 27, 2011

    Report

    Report Number
    3005099803-2011-02546
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THERE WAS A SEPARATION AT THE FLARE BETWEEN THE PTFE JACKET AND PEBAX COATING EXPOSING THE COREWIRE. IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE GUIDEWIRE STUCK TO THE SPHINCTEROTOME OF COOK (FUSION) CAUSING THE SEPARATION BETWEEN THE FLARE AND THE TIP SECTION AFTER TRY TO REMOVED IT; INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION. THEREFORE, "OPERATIONAL CONTEXT" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. A SIMILAR TREND REVIEW WAS PERFORMED AND NO OTHER COMPLAINTS REPORTED FOR LOT NUMBER 13457820. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, THE PATIENT IS OVER 18 YEARS OLD. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE GUIDEWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE WHILE CANNULATING WITH A COOK FUSION SPHINCTEROTOME , THE GUIDEWIRE BECAME STUCK IN THE SPHINCTEROTOME. WHEN THE DEVICES WERE REMOVED, THE SITE NOTED THAT THE TIP OF THE GUIDEWIRE HAD DETACHED FROM THE BODY OF THE WIRE. HOWEVER, NO PART OF THE GUIDEWIRE FEEL INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE GUIDEWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE WHILE CANNULATING WITH A COOK FUSION SPHINCTEROTOME , THE GUIDEWIRE BECAME STUCK IN THE SPHINCTEROTOME. WHEN THE DEVICES WERE REMOVED, THE SITE NOTED THAT THE TIP OF THE GUIDEWIRE HAD DETACHED FROM THE BODY OF THE WIRE. HOWEVER, NO PART OF THE GUIDEWIRE FEEL INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DREAMWIRE¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00556111 13457820

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK FUSION