BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1680796 · Received May 10, 2010

    Report

    Report Number
    1820334-2010-00203
    Event Type
    Death
    Date Received
    May 10, 2010
    Date of Event
    March 15, 2010
    Report Date
    April 13, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEATH IS UNK AS NOT PROVIDED BY REPORTER. IT IS NOT CONFIRMED THAT THE DEVICE WAS A COOK PRODUCT. EXP - UNK AS NOT PROVIDED BY REPORTER. . PATIENT CODE AND DEVICE CODE: UNK IF LABELED IN IFU AS DEVICE IS NOT CONFIRMED TO BE A COOK PRODUCT. MFR DATE: UNK AS LOT IS UNK. INVESTIGATION - EVAL: A REVIEW OF OUR RECORDS FOR THIS CUSTOMER REVEALED THAT NO COOK 12 FR OR LARGER SHEATH HAS BEEN SHIPPED DURING THE TIME BEGINNING 01/01/2007, THEREFORE, IT IS LIKELY THE SHEATHS INVOLVED IN THIS EVENT WERE FROM ANOTHER MFR. WE ARE CONTINUING OUR MONITORING OF SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THIS INFO WAS REPORTED TO ANOTHER DEVICE MFR AND PROVIDED TO COOK: THE PT PRESENTED FOR STANDARD AAA PROCEDURE WITH RIGHT HYPOGASTRIC EMBOLIZATION. THE PT HAD A RUPTURED ILIAC ARTERY AFTER REMOVAL OF THE 18 FRENCH COOK SHEATH AND SUBSEQUENTLY EXPIRED. THE PHYSICIAN WAS RE-INSERTING THE SHEATH BACK UP INTO AORTA AFTER EMBOLIZATION OF THE HYPOGASTRIC ARTERY. THE PHYSICIAN BELIEVES THE ARTERY TORE BECAUSE THE DILATOR WASN'T FULLY ADVANCED INTO SHEATH, WHEN THEY WERE RE-INSERTING THE INTRODUCER COOK SHEATH. THE REMAINING DEVICES WERE IMPLANTED WITHOUT DIFFICULTY. WHEN THE CASE WAS OVER, BEFORE REMOVING THE COOK SHEATH, THE PHYSICIAN INJECTED DYE INTO THE SHEATH TO CONFIRM THE ARTERY WAS OKAY. THE ARTERY APPEARED FINE. THE PHYSICIAN DID NOT DISCOVER THE ARTERY TO BE TORN FOR ANOTHER FEW MINUTES UNTIL THE ANESTHESIOLOGIST DETERMINED THE PT'S DRAMATIC DROP IN BLOOD PRESSURE. THE PHYSICIAN CONVERTED THE PT TO OPEN REPAIR AND OPENED THE ABDOMEN. ABDOMINAL EXPLORATION REVEALED THAT THE ILIAC ARTERY HAD RUPTURED BELOW THE AREA THAT WAS PREVIOUSLY INTERROGATED ON ANGIOGRAM. IMAGES WERE READ IN THE FIELD. UPDATE RECEIVED FROM PREVIOUSLY AREA REP 04/13/2010: THE COOK REP SPOKE TO THE TECH AT THE FACILITY. THE TEAR IN THE EXTERNAL ILIAC WAS IN THE DISTAL SIDE OF THE ARTERY. THE TECH SAID WHEN THE PHYSICIAN REINSERTED THE INTRODUCER, HE THINKS HE DIDN'T CLICK THE DILATOR ALL THE WAY IN AND THERE WAS A LIP. THE OTHER THOUGHT WAS THAT WHEN THEY REINSERTED THE 18 FRENCH SHEATH, INSTEAD OF USING THE 18 FRENCH DILATOR, THERE WAS A 12 FRENCH SHEATH ALSO OPEN ON THE TABLE, AND THEY MAY HAVE USED THAT DILATOR WHICH ALSO COULD HAVE CREATED A LIP. THEY SAID THEY DON'T KNOW FOR SURE IF EITHER OF THOSE SITUATIONS HAPPENED, STATED IT WAS A TOUGH CASE AND COULD HAVE TORN JUST FROM THE CALCIUM IN THE EXTERNAL ILIACS. THEY SAID THERE WERE NO DEFECTS WITH THE SHEATH AND DO NOT BLAME ANYTHING ON THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| R