BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN DELIVERY CATHETER

    MDR report key: 9024498 · Received September 13, 2019

    Report

    Report Number
    9024498
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 19, 2019
    Report Date
    August 30, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016641
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MICROCATHETER BROKE INSIDE OF THE REGULAR CATHETER AND WAS REMOVED FULLY, NO HARM, NO PARTS LEFT INSIDE PATIENT. NOTES FROM THE PROCEDURE: "NEXT, THE SHEATH AS WELL AS GLIDE CATHETER WAS PULLED DOWN TO THE LEVEL OF THE RIGHT COMMON ILIAC ARTERY. ANGIOGRAM PERFORMED THAT SHOWED THE PRE-EXISTING STENTS THAT WAS UNDERSIZED IN DIAMETER THAT WAS WITHIN THE ANEURYSMAL COMPONENT. THIS WAS NOTED TO BE A SELF-EXPANDING STENT. 8 MM X 60 MM POD COIL (PENUMBRA) WAS PLACED TO PACK WITHIN THE SELF-EXPANDING STENT. THIS WAS FOLLOWED BY 8 MM X 35 MM RUBY SOFT COIL. NEXT, THE MICROCATHETER WAS REMOVED AND PLACED BEHIND THE STENT WITHIN THE ANEURYSMAL PORTION. 30 CM PACKING COIL WAS INSERTED. THIS WAS INITIALLY WITHIN THE ANEURYSM, BUT THEN WAS NOTED TO TRAVEL DISTALLY INTO THE INTERNAL ILIAC ARTERY. THEREFORE, THE DECISION WAS MADE TO COMPLETE THE GRAFT DEPLOYMENT OF THE ILIAC LIMB ON THE LEFT TO EXCLUDE THE FORWARD FLOW. THE FLUSH CATHETER WAS REMOVED AND PULLED DOWN INTO THE RIGHT ILIAC ARTERY. THE MAIN BODY CAP WAS CAPTURED EXCHANGED TO A 14 FRENCH SHEATH. 16 X 10 X 82 MM LEFT ILIAC LIMB WAS MARRIED INTO THE MAIN BODY. NEXT, THE HYPOGASTRIC ARTERY WAS SELECTED, AND ENSNARE INSERTED TO CAPTURE THE MIGRATED COMPONENT OF THE PACKING COIL. THIS WAS SUCCESSFULLY ABLE TO BE SNARED OUT IN ENTIRETY THROUGH THE RIGHT GROIN. THE CATHETER AND WIRE REMOVED, AND ADDITIONAL RUBY SOFT COIL WAS INSERTED WITHIN THE ANEURYSM SAC."... THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817010 LANTERN DELIVERY CATHETER CATHETER, PERCUTANEOUS DQY PENUMBRA, INC. PXSLIMLAN135STR F87597 00814548016641

    Patients

    Seq Age Sex Outcome Treatment
    1 30295 DA