BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1051436 · Received May 21, 2008

    Report

    Report Number
    3005099803-2008-00512
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED, BUT THE DEVICE EVAL IS NOT COMPLETE; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND THE CAUSE OF THE NEEDLE RETRACTION FAILURE IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT. THE APRIL 2008 15-MONTH INJECTION GOLD PROBE HEMOSTASIS CATHETER PRODUCT FAMILY COMPLAINT TREND REPORT. INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    AN INJECTION GOLD PROBE BIPOLAR CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN AN ADULT MALE PT (AGE AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, "THE NEEDLE WAS DEPLOYED OUT OF THE BOX. IT WAS NOTICED AFTER IT WENT THROUGH THE ENDOSCOPE. NO [ENDO] SCOPE DAMAGE WAS REPORTED. THE DEVICE WAS REMOVED FROM THE [ENDO] SCOPE WITH THE NEEDLE DEPLOYED.' THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND INJECTION GOLD PROBE BIPOLAR CATHETER. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 11005657

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK