BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1051435 · Received May 21, 2008

    Report

    Report Number
    3005099803-2008-00515
    Event Type
    Malfunction
    Date Received
    May 21, 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
    NURSE

    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 REPORTED TIP DETACHMENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT. THE 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

    NOTE: THE DATE OF EVENT IS UNKNOWN. AN INJECTION GOLD PROBE BIPOLAR CATHETER WAS INTENDED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN AN ADULT PT (AGE, GENDER AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING PREPARATION IT WAS OBSERVED THAT THE "DISTAL TIP WAS BROKEN OFF THE DEVICE." THIS DEVICE WAS NOT USED; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND INJECTION GOLD PROBE BIPOLAR CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 9531147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK