BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKDRAW VENOUS CANNULA

    MDR report key: 3746785 · Received April 11, 2014

    Report

    Report Number
    3008500478-2014-00053
    Event Type
    Death
    Date Received
    April 11, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 17, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K962835
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETAINED BY THE HOSPITAL FOR EVALUATION. AT THIS TIME, THERE IS NO ALLEGATION OF PRODUCT MALFUNCTION BUT ONLY AN ADVERSE EVENT ASSOCIATED WITH THE USE OF AN EDWARDS DEVICE. THE DEVICE WAS DISCARDED AT THE HOSPITAL. INJURIES TO THE VASCULATURE IN WHICH THE DEVICE IS INSERTED IS LISTED AS A POTENTIAL COMPLICATION IN THE PRODUCT IFU. THE IFU FURTHER NOTES: CAUTION: ENSURE THAT THE VESSEL IS OF ADEQUATE SIZE TO ALLOW DISTAL PERFUSION OF LIMB WHEN CANNULA IS IN PLACE. WARNING: IF INCREASED RESISTANCE IS FELT AT ANY TIME UPON INSERTION OR REMOVAL OF THE GUIDEWIRE, DILATORS, INTRODUCER, OR CANNULA, INVESTIGATE THE CAUSE BEFORE CONTINUING. FLUOROSCOPY IS RECOMMENDED FOR DIAGNOSING IMPAIRED BLOOD FLOW OR INCREASED INSERTION/REMOVAL RESISTANCE NO DEVICE MALFUNCTION IS INDICATED IN THE REPORT AND THE EVENTS REPORTED ARE INCLUDED IN THE LABELING. NO ACTIONS ARE NEEDED AT THIS TIME. FOR COMPLAINTS/REPORTS OF INJURY WITHOUT A PRODUCT PROBLEM, THIS TYPE OF EVENT IS A KNOWN POTENTIAL COMPLICATION OR ADVERSE EVENT, IS INCLUDED IN THE LABELING/TRAINING MATERIALS, AND IN THE INFORMATION WE PROVIDE TO HELP AVOID THE ISSUE. ALL LABELING AND TRAINING APPROPRIATELY ADDRESS THE RISK. MANUFACTURING RECORDS COULD NOT BE REVIEWED AS A LOT NUMBER IS UNKNOWN. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE USE OF EDWARDS QUALITY SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF A QD25 "THE ILIAC VEIN WAS INJURED DURING FEMORAL CANNULATION". PLANNED PROCEDURE WAS REDO CABG. PT EXPIRED. THE PHYSICIAN IS EXPERIENCED WITH FEMORAL CANNULATION. ADDITIONAL INFORMATION: THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE. THE HOSPITAL WAS UNABLE TO PROVIDE INFORMATION AS TO WHETHER THE PATIENT WAS KNOWN TO HAVE TORTUOUS ANATOMY BUT STATED THAT THIS WAS NOT HER FIRST PROCEDURE. ADDITIONAL INFORMATION: THE CANNULA WAS PLACED THROUGH PERCUTANEOUS PLACEMENT, FOLLOWED BY OPEN AFTER THE DAMAGE. THE CUSTOMER IS UNSURE WHETHER THE VESSEL WAS DAMAGED BY THE CANNULA OR QD INTRODUCER. THERE WERE MULTIPLE VESSELS INJURED, ILIAC AND SVC. THE VESSEL WAS REPAIRED THROUGH EXPLORATORY LAP. THE VESSEL DAMAGE IS REPORTED TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH. THE CUSTOMER IS UNABLE TO ANSWER WHAT THE CAUSE OF DEATH WAS. THE CUSTOMER IS UNABLE TO PROVIDE ANY ADDITIONAL PATIENT INFORMATION OR OP NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221057 QUICKDRAW VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES QD25

    Patients

    Seq Age Sex Outcome Treatment
    1 Death