BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUIDE WIRE

    MDR report key: 448733 · Received March 6, 2003

    Report

    Report Number
    6000136-2003-00001
    Event Type
    Death
    Date Received
    March 6, 2003
    Date of Event
    January 28, 2003
    Report Date
    February 5, 2003
    Manufacturer
    LAKE REGION MFG, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA TREATMENT PROCEDURE, WIRE REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PT WAS FOUND TO HAVE IN-STENT RESTENOSIS IN ALL 3 VESSELS, WITH A SUB-TOTAL OCCLUSION IN THE CIRCUMFLEX. IT WAS ALSO NOTED THAT THE MAMMARY ARTERY GRAFT TO THE DISTAL LAD WAS PATENT. THE ZETA STENTS THAT HAD BEEN PLACED IN THE LEFT CORONARY ARTERY SYSTEM APPARENTLY WERE IN A Y FORMATION. IT WAS DECIDED THAT THE PT WOULD UNDERGO PTCA OF THE OSTIAL CIRCUMFLEX STENT RESTENOSIS TO INCREASE THE FLOW TO THAT VESSEL, WHILE WAITING FOR A HEART TRANSPLANT. THE PHYSICIAN ATTEMPTED TO ADVANCE THE WIRE ACROSS THE LESION, MET WITH RESISTANCE AND THEN WAS UNABLE TO REMOVE IT. UPON ATTEMPTING TO REMOVE THE WIRE, IT FRACTURED AND THE DISTAL SEGMENT REMAINED IN THE CIRCUMFLEX AND LEFT MAIN CORONARY ARTERIES. THE PT WAS STABLE AT THE TIME OF THIS EVENT BUT AN INTRA-AORTIC BALLON PUMP WAS INSERTED PROPHYLACTICALLY. THEY WERE TRANSFERRED TO CCU IN STABLE CONDITION AND THEY UNDERWENT TRIPLE BYPASS SURGERY AND REMOVAL OF THE WIRE FRAGMENT LATER THAT DAY. THEY WERE TRANSFERRED TO ICU FOLLOWING THE SURGERY, BUT BECAME HEMODYNAMICALLY UNSTABLE. USE OF A LEFT VENTRICULAR DEVICE WAS DISCUSSED, BUT THE PT AND THEIR FAMILY DECIDED THAT THEY DID NOT WANT ADD'L SURGERY. PT EXPIRED THE NEXT DAY. THE PHYSICIAN INDICATED THEY DID NOT BELIEVE THERE WAS A PRODUCT PROBLEM, BUT THAT HE ENCOUNTERED PROCEDURAL DIFFICULTIES, DUE TO THE PT'S CONDITION. NO AUTOPSY WAS PERFORMED, THEREFORE THE EXACT CAUSE OF DEATH IS UNKOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE PTCA GUIDEWIRE DQX LAKE REGION MFG, INC. MODEL-185-PATRIOT MOD SUP JT 01942374

    Patients

    Seq Age Sex Outcome Treatment
    1 Death