BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOS SOFT VU TIP

    MDR report key: 3193426 · Received June 21, 2013

    Report

    Report Number
    MW5030657
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CALLED IN FOR HEPATIC EMBOLIZATION AT 1200 MIDNIGHT. SOS OMNI SELECTION CATHETER OPENED FOR PROCEDURE. CATHETER FLUSHED NO DEFECTS OBSERVED. CATHETER LOADED ONTO WIRE, AFTER WIRE REMOVED, CONTRAST HAND INJECTION BY PHYSICIAN. AT SOME POINT DURING THAT TIME, PHYSICIAN NOTICED CATHETER WAS DETACHED, LEAVING A PIECE OF CATHETER IN THE CELIAC ARTERY. AT THIS POINT PHYSICIAN MADE MULTIPLE ATTEMPTS WITH NUMEROUS SNARE CATHETERS TO REMOVE THE LODGED PIECE BUT WAS UNSUCCESSFUL. POWER INJECTION WAS MADE TO DETERMINE IF THE PIECE WAS OBSTRUCTING ARTERY AS WELL TO IDENTIFY ANY BLEED. DECISION MADE PIECE NOT OBSTRUCTING. DECISION MADE BY SURGEON NOT TO TAKE TO SURGERY. AFTER PROCEDURE WAS DONE INCIDENTAL, FINDING OF ANOTHER FRACTURED PIECE OF CATHETER LEFT IN PACKAGE. CATHETER AS WELL AS PACKAGING SAVED TO BE TURNED INTO RISK MANAGEMENT. REASON FOR USE: LIVER METS - HEPATIC EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281678 SOS SOFT VU TIP SOS CATHETER DQO ANGIODYNAMICS 528800

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR