BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER

    MDR report key: 1011925 · Received March 10, 2008

    Report

    Report Number
    6000002-2008-06181
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    November 15, 2007
    Report Date
    November 26, 2007
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED AND EVALUATED. EXAMINATION REVEALED THAT THE BALLOON LATEX WAS NOT ATTACHED TO THE CATHETER BODY AT BOTH DISTAL AND PROXIMAL BOND AREAS. IT APPEARED THAT THE BALLOON LATEX WAS INSUFFICIENTLY BONDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE AND THE BALLOON COULD NOT MAINTAIN INFLATION BEFORE USE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER THERMODILUTION CATHETHER DYG EDWARDS LIFESCIENCES PR 096F6 58340351

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other