BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1181900 · Received September 25, 2008

    Report

    Report Number
    6000002-2008-08760
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K924661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH DEVICES WAS RETURNED AND EVALUATED. THE FIRST UNIT'S EXAMINATION REVEALED THAT THE CUSTOMER REPORT OF BALLOON ISSUE WAS NOT CONFIRMED. BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED WITHIN ENGINEERING SPEC. THE EXAMINATION OF THE SECOND UNIT REVEALED THAT THE CUSTOMER REPORT WAS CONFIRMED. BALLOON RUPTURED ALMOST HALF WAY AROUND THE CIRCUMFERENCE. THE EDGES OF THE RUPTURED PORTION DID NOT MATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETERS WERE DEFECTIVE. TWO CATHETERS WERE REPORTED. NO MORE INFO AVAILABLE. IT WAS FURTHER STATED THAT THE BALLOON WAS MOST PROBABLY DEFECTIVE. FOLLOW UP WITH CUSTOMER INDICATED THAT BEFORE FORWARDING THE CATHETERS FOR EVAL, IT WAS OBVIOUS THAT THE BALLOON HAD A DEFECT. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 139HF75P UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other