BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2501927 · Received March 23, 2012

    Report

    Report Number
    2015691-2012-17153
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 27, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    KRB
    PMA / PMN Number
    K811411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED WITH AN ATTACHED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. EXAMINATION REVEALED THAT THE BALLOON WAS TORN OFF IN THE CENTRAL AREA AROUND THE CIRCUMFERENCE OF THE BALLOON. THE LATEX WAS VISIBLE ON BOTH PROXIMAL AND DISTAL BONDS. BALLOON LATEX WAS NOT RETURNED WITH THE CATHETER. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO VISIBLE DAMAGE OBSERVED FROM THE CATHETER BODY OR THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE BALLOON DAMAGE REPORTED WAS CONFIRMED; THE CATHETER WAS RETURNED WITH THE BALLOON TORN OFF. THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE WEDGE POSITION, THE BALLOON LOST AIR. THE CATHETER WAS REMOVED AND THE BALLOON WAS FOUND MISSING. POSSIBLY IT GOT STUCK INSIDE THE 8F SHEATH. NO PATIENT INJURY WAS REPORTED. BEFORE USE THEY CHECKED THE BALLOON AND EVERYTHING WAS FINE. UNFORTUNATELY, THE SHEATH WAS DISCARDED AND THEREFORE IT COULD NOT BE CONFIRMED IF THE BALLOON FRAGMENTS ARE INSIDE THE SHEATH. THE PATIENT WAS DOING FINE. AS REPORTED, THERE ARE NO ACTIONS PLANNED TO "SEARCH" FOR THE MISSING BALLOON. THE PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD THERMODILUTION CATHETER KRB EDWARDS LIFESCIENCES, PR 131HF7 58942079

    Patients

    Seq Age Sex Outcome Treatment
    1