BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST CATH, 11F, 12CM

    MDR report key: 1044650 · Received May 12, 2008

    Report

    Report Number
    MW5006835
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ST. JUDE MEDICAL CENTER
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT FOR A FIB ABLATION. CARDIOLOGIST GAINED VENOUS ACCESS VIA THE LEFT FEMORAL VEIN, USING TWO DAIG 6.5F, 12CM FAST CATH HEMOSTASIS INTRODUCERS, MODEL 406153. LOT #QUESTIONABLE AS PACKAGING FOR THE CASE WAS NOT RETAINED LOTS 2061262 OR 2057363 SUSPECTED. AN 11F, 12CM FAST CATH INTRODUCER, MODEL 406124, WAS PLACED IN THE SAME VEIN. ALL THREE INTRODUCERS PLACED IN THE FOLLOWING MANNER: THREE SEPARATE NEEDLE STICKS PERFORMED, GUIDE WIRES PLACED INTO VEIN WITH EACH STICK, NEEDLE REMOVED OVER THE GUIDE WIRE RESPECTIVELY. ONCE ALL THREE GUIDE WIRES IN PLACE, INTRODUCERS WITH DILATORS PLACED AND GUIDE WIRES AND DILATORS WERE REMOVED. SIDE PORTS OF 6.5F INTRODUCERS WERE USED FOR BLOOD DRAW WITHOUT RESISTANCE. UPON CONCLUSION OF CASE, WHEN REMOVING THE 6.5F INTRODUCERS, ONE OF THEM WAS REMOVED, YIELDING ONLY THE HUB AND A SMALL PIECE OF THE SHAFT COMPONENT. FLUOROSCOPY REVEALED THE INTRODUCER SHAFT REMAINED IN THE FEMORAL VEIN, JUST BEYOND THE INSERTION SITE WITHOUT DISTAL MIGRATION. THE 11F INTRODUCER IN THE LEFT IN PLACE TO MAINTAIN STABILITY IN THE AREA. ATTEMPTS TO REMOVE INTRODUCER IN THE EP LAB INCLUDED SUPERFICIAL CUT DOWN, AND ATTEMPT TO RETRIEVE VIA SNARE. FOLLOWING THESE UNSUCCESSFUL ATTEMPTS PT TO OR FOR SUCCESSFUL VASCULAR SURGICAL CUT DOWN WITHOUT FURTHER COMPLICATION. DISCHARGED HOME IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST CATH, 11F, 12CM HEMOSTASIS INTRODUCER DYB ST. JUDE MEDICAL CENTER 406153 2061262

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability