BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER AMC THROMBOSHIELD

    MDR report key: 2964068 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19296
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER THAT WAS RETURNED FOR EVALUATION CONTAINED SIGNIFICANTLY MORE DAMAGE THAN THE ORIGINAL REPORT INDICATED. THE SWAN-GANZ CATHETER WAS RETURNED WITHOUT THE SYRINGE, CONTAMINATION SHIELD OR INTRODUCER. THE CAL-CUP WAS NOT RETURNED WITH THE CATHETER. AS RECEIVED, THE BALLOON WAS NOT FOUND ON THE CATHETER BUT BOTH SIDES OF THE BALLOON BONDINGS REMAINED. THE EDGE OF THE REMAINING BALLOON FRAGMENT APPEARED ROUGH. NO VISIBLE DAMAGE TO THE CATHETER BODY WAS OBSERVED. VISUAL EXAMINATIONS WERE PERFORMED AT 10X MAGNIFICATION AND WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE COMPLAINT WAS CONFIRMED DURING THE EVALUATION BUT THERE WAS NO INDICATION OF A MANUFACTURING NONCONFORMANCE NOTED DURING THE ANALYSIS. IT APPEARS THAT THE BALLOON MAY HAVE BEEN TORN OFF DURING REMOVAL OF THE CATHETER FROM THE CAL-CUP WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING BUT THIS COULD NOT BE CONCLUSIVELY DETERMINED WITHOUT RETURN OF THE PACKAGING. (B)(4) DO INSTRUCT THE USER HOW TO PROPERLY REMOVE THE CATHETER TIP FROM THE CAL-CUP TO AVOID DAMAGE TO THE BALLOON LATEX. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT "THE BALLOON DID NOT INFLATE AT THE INFLATION TEST BEFORE USE." THE CATHETER WAS NOT USED AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67375 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER AMC THROMBOSHIELD SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER AMC THROMBOSHIELD DYG EDWARDS LIFESCIENCES, PR 746HF8J 59312628

    Patients

    Seq Age Sex Outcome Treatment
    1