BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ SUPERSTIFF GUIDEWIRE

    MDR report key: 2001509 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00505
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 4, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPERSTIFF GUIDEWIRE WAS USED IN A PCNL PROCEDURE. ACCORDING TO THE COMPLAINANT, THE AMPLATZ SUPERSTIFF GUIDEWIRE WAS PLACED WITHIN THE PATIENT RANGING FROM THE KIDNEY TO THE URINARY BLADDER. THE PCNL PROCEDURE WAS REPORTEDLY SUCCESSFUL. UPON WITHDRAWAL OF THE AMPLATZ SUPERSTIFF GUIDEWIRE FROM THE PATIENT, THE WIRE BECAME "CAUGHT ON SOMETHING." THE WIRE WAS THEN PULLED WITH MORE FORCE AT WHICH TIME THE PTFE COATING UNCURLED AND SEPARATED FROM THE STAINLESS STEEL CORE OF THE GUIDEWIRE. IN ADDITION, THE DOCTOR'S FINGER WAS POKED WITH THE EXPOSED STAINLESS STEEL END OF THE GUIDEWIRE. THE DOCTOR IS CURRENTLY UNDERGOING A SERIES OF LAB TESTING TO ENSURE NO DISEASES WERE TRANSMITTED FROM THE PATIENT TO THE DOCTOR VIA THE GUIDEWIRE THE PATIENT CONDITION WAS UNKNOWN AT THE CONCLUSION OF THE PROCEDURE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPERSTIFF GUIDEWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA UNK18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention