BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH AMC THROMBOSHI

    MDR report key: 3073053 · Received April 23, 2013

    Report

    Report Number
    2015691-2013-19886
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED WITHIN 2 SECONDS WITHOUT A SYRINGE ATTACHED, WHICH IS WITHIN THE ALLOWABLE SPECIFICATION. BALLOON FAILED TO DEFLATE FULLY WITH RETURNED SYRINGE ATTACHED. PER IFU, 'PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE.' 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 COMPLAINT OF BALLOON DEFLATION COULD NOT BE CONFIRMED DURING ANALYSIS. EVEN THOUGH THE BALLOON MAY DEFLATE WITH THE SYRINGE ATTACHED, THE CATHETER WAS DESIGNED TO BE PASSIVELY DEFLATED WITH THE SYRINGE REMOVED. ALL SWAN-GANZ IFUS INSTRUCT THE CLINICIAN TO "PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE". AFTER DEFLATION, THE SYRINGE SHOULD BE RE-ATTACHED TO THE GATE VALVE. THE FRICTION BETWEEN THE SYRINGE BARREL AND PLUNGER MAY BE TOO GREAT FOR THE ELASTICITY OF THE BALLOON LATEX TO OVERCOME; THEREFORE, THIS IS NOT A RELIABLE METHOD FOR DEFLATION. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE BALLOON DIDN'T DEFLATE PASSIVELY WITH THE SYRINGE DETACHED WHEN TESTED BEFORE USE; THEREFORE, THE DEVICE WAS NOT USED. THE SALES REP WAS AT THE HOSPITAL WHEN THE EVENT OCCURRED AND STATED THAT IT HAPPENED AS DESCRIBED EVEN THOUGH HE TESTED THE BALLOON 2 MINUTES BEFORE AND IT DEFLATED PASSIVELY EVEN WITH SYRINGE ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174315 SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH AMC THROMBOSHI CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 831HF75 59304162

    Patients

    Seq Age Sex Outcome Treatment
    1