BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE TD CATHETER

    MDR report key: 2872224 · Received December 13, 2012

    Report

    Report Number
    2015691-2012-18839
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQO
    PMA / PMN Number
    K915726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WITH MONOJECT 1.5CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. NO INTRODUCER WAS RETURNED. THE BALLOON DID NOT INFLATE DUE TO AN INTERLUMEN LEAKAGE IN THE BACKFORM BETWEEN THE INFLATION AND DISTAL LUMENS. EXAMINATION OF THE CATHETER FOUND THE DISTAL LUMEN TO BE FULLY OCCLUDED. THE PROXIMAL LUMEN WAS FOUND TO BE PATENT AND DID NOT LEAK. THE BALLOON INFLATED ALTHOUGH IT WAS FOUND TO HAVE WHAT APPEARS TO BE BLOOD ON THE INSIDE SURFACE OF THE LATEX. THE OCCLUSION IN THE DISTAL LUMEN WAS CLEARED USING HOT WATER AND A STYLET WIRE. LEAK TESTING WAS THEN PERFORMED AND THE DISTAL LUMEN WAS FOUND TO LEAK INTO THE INFLATION LUMEN FROM THE INSIDE THE BACKFORM. THIS CONDITION CONFIRMS THE CUSTOMER REPORT OF BALLOON COULD NOT MAINTAIN INFLATION DURING USE. BALLOON INFLATION TEST WAS PERFORMED USING RETURNED SYRINGE WITH 1.5CC AIR. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION AND WITH UNAIDED EYE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION AT THE TIME OF RELEASE. THE CUSTOMER REPORT WAS CONFIRMED AS RELATED TO THE MANUFACTURING PROCESS. AN INVESTIGATION IS UNDERWAY TO DETERMINE WHAT ACTIONS ARE NEEDED TO PREVENT RECURRENCE OF THIS TYPE OF COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON COULD NOT MAINTAIN INFLATION DURING USE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE TD CATHETER SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE TD CATHETER DQO EDWARDS LIFESCIENCES, PR 174HF7 59335167

    Patients

    Seq Age Sex Outcome Treatment
    1