BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPOLAR PACING CATHETER

    MDR report key: 1103625 · Received August 5, 2008

    Report

    Report Number
    1103625
    Event Type
    Other
    Date Received
    August 5, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 5, 2008
    Manufacturer
    EDWARDS LIFE SCIENCES, LLC
    Product Code
    DYG
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO CARDIAC CATH LAB FOR PLACEMENT OF A TEMPORARY PACEMAKER, CCL PERSONNEL REPORTED THAT WHILE ATTEMPTING TO PLACE SWAN GANZ BIPOLAR PACING CATHETER, USING RIGHT GROIN APPROACH, STAFF WENT THROUGH MULTIPLE (APPROX SIX) CATHETERS DUE TO BALLOON RUPTURE. SOME RUPTURED PRIOR TO INSERTION AND SOME RUPTURED AFTER INSERTION WHILE TRYING TO BE PLACED AFTER BEING INFLATED AND DEFLATED A COUPLE OF TIMES. AT LEAST, THREE OF THE CATHETER BALLOONS WERE RUPTURED PRIOR TO INSERTION, THEY WOULD NOT INFLATE RIGHT OUT OF THE BOX PACKAGING. CCL STAFF RAN OUT OF STOCK CATHETERS, OBTAINED MORE FROM A CRITICAL CARE UNIT WHICH RESULTED IN THE SAME SCENARIO. THE PHYSICIAN DETERMINED THAT DUE TO THE SITUATION, A PERMANENT PACEMAKER WAS NECESSARY AT THAT POINT. STAFF REPORTED THAT THE CATHETERS WERE FROM DIFFERENT LOT NUMBERS, ALL WITH EXP DATES OF 2009 AND 2010. THE COMPANY WAS CONTACTED ON 7/25/08. (2 AFFECTED UNITS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR PACING CATHETER SWAN-GANZ CATHETER DYG EDWARDS LIFE SCIENCES, LLC 58460980
    2 BIPOLAR PACING CATHETER SWAN-GANZ CATHETER DYG EDWARDS LIFESCIENCES, LLC 58436341
    3 BIPOLAR PACING CATHETER SWAN-GANZ CATHETER DYG EDWARDS LIFE SCIENCES, LLC 58519970
    4 BIPOLAR PACING CATHETER SWAN-GANZ CATHETER DYG EDWARDS LIFE SCIENCES, LLC 58429630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ARROW PERCUTANEOUS SHEATH INTRODUCER