BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 3778159 · Received April 29, 2014

    Report

    Report Number
    2015691-2014-00980
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 13, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    KRB
    PMA / PMN Number
    K811411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE 131HF7 CATHETER WITH AN ATTACHED MONOJECT 1.5CC LIMITED VOLUME SYRINGE FOR EXAMINATION. THE REPORTED EVENT OF "BALLOON BURST" WAS CONFIRMED. THE BALLOON HAD A RUPTURE PROXIMAL OF THE DISTAL BOND. EDGES OF THE LATEX DID NOT APPEAR TO MATCH UP AND HAD A GAP OF MISSING LATEX. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO VISIBLE DAMAGE OBSERVED FROM THE CATHETER BODY OR RETURNED SYRINGE. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. LOT NUMBER WAS NOT PROVIDED, THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BURST BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257165 SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD PROBE, THERMODILUTION KRB EDWARDS LIFESCIENCES PR 131HF7

    Patients

    Seq Age Sex Outcome Treatment
    1