BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK CROSS

    MDR report key: 2050308 · Received April 6, 2011

    Report

    Report Number
    MW5020203
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TAKEN TO THE CATH LAB, RIGHT GROIN WAS STERILELY PREPPED AND DRAPED IN THE USUAL FASHION. I PLACED A 6-FRENCH SHEATH INTO THE RIGHT COMMON FEMORAL ARTERY, BROUGHT AN IM CATHETER AND A GLIDEWIRE INTO THE LEFT SFA. PRIOR TO DOING THIS, I DID A RIGHT LEG ANGIOGRAM WHICH SHOWED THAT THE PT HAD SFA THAT WAS PATENT WITH SOME POPLITEAL DISEASE, BUT A PROFUNDA WAS HEAVY NARROWED WHICH WILL REQUIRE PROFUNDA ENDARTERECTOMY IN THE FUTURE ON THE RIGHT SIDE. TURING OUR ATTENTION TO THE LEFT SIDE, I UNFORTUNATELY HAD A FRACTURE OF THE QUICK-CROSS CATHETER WHICH ADHERED ON THE SUPERCORE WIRE DOWN AT THE SFA ADDUCTOR CANAL. I WAS ABLE EVENTUALLY TO TAKE THIS OUT OVER A SNARE DEVICE USING A BALKAN 7-FRENCH CATHETER AND SHEATH. ONCE I HAD THE QUICK-CROSS CATHETER TIP, WHICH WAS ADHERED TO THE SFA REMOVED, I THEN ONCE AGAIN CROSSED THE SFA AND THE ADDUCTOR CANAL STENOSIS WITH A GLIDEWIRE, PLACED A ROSEN WIRE DOWN AND THEN I PLACED A STANDARD 014 STEEL WIRE WITH A FILTER FROM ABBOTT FOR DISTAL PROTECTION INTO THE POPLITEAL REGION. WITH THIS DISTAL PROTECTION IN PLACE WITH A 014 STEEL CORE WIRE, WE WERE ABLE TO USE A 2.0 LASER FOR THE LASER ATHERECTOMY OF THE SFA AND THE POPLITEAL ARTERY. THIS WAS DONE W/O ANY DIFFICULTY. WE HAD A GOOD RESULT WHICH WE ANGIOPLASTIED WITH 6 MM BALLOON. THIS WAS DONE OF THE SFA AND THE POPLITEAL. THE OUTFLOW WAS 3 VESSELS. THE PROXIMAL SFA AND PROFUNDA WERE PATENT AS WAS THE COMMON FEMORAL ARTERY. WE WERE ABLE TO DO THIS WITH 5000 UNITS OF HEPARIN WITH AN EXCELLENT RESULT. WE THEN REMOVED THE SHEATHS AND WIRES AND USED A 6-FRENCH STAR CLOSURE FOR THE RIGHT COMMON FEMORAL ARTERY. BASICALLY, THE PROCEDURE REQUIRED REMOVAL OF FRACTURED QUICK-CROSS CATHETER, WHICH FRACTURED PROBABLY WITH A STEEL CORE WIRE IN GOING UP AND OVER ON THE HORN. WE WERE ABLE TO TRAP THIS WITH A SNARE AND BRING IT OUT THROUGH THE BALKIN SHEATH. OVERALL, THE PT DID VERY WELL AND THE LASER ATHERECTOMY AND THE ANGIOPLASTY WERE DONE W/O DIFFICULTY. FOREIGN BODY EXTRACTION WAS NECESSARY BECAUSE I DID NOT WANT TO LEAVE THE QUICK-CROSS CATHETER PIECE IN ADHERED TO THE SFA. THE PT OVERALL TOLERATED PROCEDURE WELL. THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK CROSS SUPPORT CATHETER DQY FQC11B10D

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Disability