BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRAJAGWIRE

    MDR report key: 2254251 · Received September 19, 2011

    Report

    Report Number
    3005099803-2011-03139
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 HYDRAJAG GUIDEWIRE WAS USED DURING A CYST GASTROSTOMY IN THE STOMACH ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE COATING OF THE HYDRAJAG PEELED, AND THE TIP OF THE GUIDEWIRE DETACHED AND FELL INTO THE STOMACH OF THE PATIENT. ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE, BUT THEY WERE UNSUCCESSFUL. THERE IS NO FURTHER PLANNED INTERVENTION TO RETRIEVE THE DETACHED TIP AT THIS TIME. THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDEWIRE WITH NO ADDITIONAL PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAJAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00556021 14249155

    Patients

    Seq Age Sex Outcome Treatment
    1 Other