BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMWIRE

    MDR report key: 1779077 · Received August 2, 2010

    Report

    Report Number
    3005099803-2010-03391
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS NOT KNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. NON-SURGICAL MEDICAL INTERVENTION WAS PERFORMED TO REMOVE THE DETACHED TIP FROM THE COMMON BILE DUCT. 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 AND THE ROOT CAUSE COULD NOT BE DETERMINED. 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 THAT A DREAMWIRE GUIDEWIRE WAS USED DURING THE DEPLOYMENT OF AN ENDOSCOPIC NASOBILIARY DRAINAGE TUBE (ENBD) ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN TRIED TO DEPLOY THE ENBD TUBE IN THE BILE DUCT, THE TIP OF THE GUIDEWIRE DETACHED. THEY RETRIEVED THE TIP OF THE GUIDEWIRE BY USING A FORCEPS. THE ENBD TUBE WAS SUCCESSFULLY IMPLANTED USING ANOTHER DREAMWIRE GUIDEWIRE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DREAMWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - MIAMI M00556151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other