BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 1601076 · Received February 9, 2010

    Report

    Report Number
    2522007-2010-00001
    Event Type
    Death
    Date Received
    February 9, 2010
    Date of Event
    November 9, 2009
    Report Date
    February 3, 2009
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    PMA / PMN Number
    K010055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED INFORMATION CONCERNING THE AUTOPSY REPORT FROM DR INVOLVED. SENIOR PRODUCT MANAGER - (B) (4), RESPONDED ON 01/12/2010: "DO NOT HAVE A COPY OF THE AUTOPSY REPORT. DUE TO THE DIFFICULT CIRCUMSTANCES AND PRIVACY ISSUES AROUND THIS CASE, IT IS PREFERABLE AND I BELIEVE PROFESSIONALLY MORE APPROPRIATE THAT SUCH A QUERY AS IS REQUESTED DIRECTLY BY COOK IN RESPONSE TO OUR REPORT. ON 01/20/2010: REQUESTED THE AUTOPSY REPORT FROM PHYSICIAN INVOLVED. TO DATE ((B) (4) 2010) WE HAVE NOT RECEIVED A RESPONSE FROM THE PHYSICIAN. ENGINEERING REPORTED, " THE EVOLUTION IN QUESTION WAS NOT RETURNED FOR EVALUATION. THUS LEAVING US WITH NO WAY TO INVESTIGATE ANY POSSIBLE FAILURE OR MALFUNCTION OF THE DEVICE ITSELF. ALL THAT WAS RETURNED TO US WAS THE TEFLON OUTER SHEATH WHICH UPON VISUAL EXAMINATION WAS FOUND TO BE PERFECTLY STRAIGHT, HOWEVER, THE TAPERED END OF THE SHEATH HAD SUSTAINED SUBSTANTIAL DAMAGE." ENGINEERING REPORTED, "ADMITTEDLY THE DEVICE WAS USED IN A WAY THAT IS NOT ACCORDING TO THE INSTRUCTIONS FOR USE. THIS COULD IMPLY THAT THE EVENT MAY HAVE COME ABOUT AS A RESULT OF THE WAY IN WHICH THE DEVICE WAS USED. SINCE THE EVOLUTION MECHANICAL DILATOR, LR-EVN-13.0 WAS NOT RETURNED FOR EVALUATION, WE CANNOT DETERMINE IF IT WAS DAMAGED OR MALFUNCTIONING AT THE TIME OF USE AND CANNOT CONCLUDE ONE WAY OR THE OTHER REGARDING ITS INVOLVEMENT IN THE INCIDENT REPORTED. THE DAMAGE TO THE SHEATH THOUGH EXTENSIVE IS STILL CONSISTENT WITH THE TYPE OF DAMAGE A TEFLON SHEATH CAN SUSTAIN WHEN SUBJECTED TO A DIFFICULT PROCEDURE." (B) (4)

    Description of Event or Problem · 1

    COMPLAINT REPORT STATES, AS REPORTED BY (B) (6), "THE CASE PROCEEDED AS PLANNED WITH VASCULAR SURGEON ((B) (6)) PERFORMING RIGHT NECK ACCESS AND EXPOSURE OF THE TESIO CATHETER IN SITU. GROIN ACCESS WAS SECURED VIA A 12FR SHEATH FROM THE NEEDLE EYE SNARE SET. THRU AND THRU WIRES (AMPLATZ EXTRA STIFF 0.035" 180CM LENGTHS) WERE PASSED THROUGH BOTH CATHETER LUMENS. ATTEMPT MADE TO SNARE BOTH CATHETERS TOGETHER FROM FEMORAL ACCESS WITH 25MM GOOSENECK SNARE: UNSUCCESSFUL IN SECURING BOTH LEADS TOGETHER, SO SNARE REMOVED AND PRELOADED THROUGH INTO 13FR EVOLUTION SHEATH FOR PLANNED ACCESS VIA RIGHT INTERNAL JUGULAR/INNOMINATE. BOTH TESIO CATHETERS WERE SECURED WITH EXTERNAL VESSEL LOOPS FOR FURTHER CONTROL: INITIAL PASS OF EVOLUTION SHEATH (WITH SNARE PRELOADED) CUT THROUGH ONE OF THE VESSEL LOOPS. THIS VESSEL LOOP WAS REMOVED, REPLACED AND SECURED ONCE MORE. SUTURE REPAIR ATTEMPTED FOR HEMOSTATIC CONTROL WITH 3-0 PROLENE SUTURE- ACCESS AGAIN ATTEMPTED WITH SNARE PRELOADED: DECISION BY TEAM TO REMOVE SNARE AS IT WAS PERCEIVED TO BE IMPINGING BETWEEN SHEATH AND VESSEL. FURTHER ATTEMPT TO PASS EVOLUTION SHEATH OVER AMPLATZ EX STIFF: EVOLUTION ACTIVATED WITH TENSION++ ON BEING APPLIED ON DEVICE AS WELL AS BOTH PROXIMAL AND DISTAL WIRES. EXTERNAL TEFLON SHEATH OF EVOLUTION DEVICE REPOSITIONED, ATTEMPTED TO USE ROTATING MECHANISM OF EVOLUTION SHEATH AGAIN: SUDDEN RELAXING OF ACCESS/ANATOMY NOTICED AND FELT BY DOCTORS INVOLVED." "ANATOMY REIMAGED AND INSTANT PNEUMOTHORAX NOTICED BY RADIOLOGISTS, BLOOD ++ VIA NECK: IMMEDIATE ATTEMPT TO GAIN HEMOSTATIC CONTROL AT NECK BY PLACING 22FR SHEATH OVER WIRES ONCE EVOLUTION SHEATH REMOVED. ALL CARDIAC OUTPUT LOST. CPR COMMENCED IMMEDIATELY, BLOOD CALLED FOR AND GIVEN UPON ARRIVAL. 22FR HEMOSTATIC SHEATH LOST DURING REPOSITIONING, 20FR SHEATH PLACED FOR MINIMAL HEMOSTATIC CONTROL (ONLY SIZE AVAILABLE FOR IMMEDIATE USE), PATIENT TRANSFERRED TO OT FOR IMMEDIATE THORACOTOMY/BYPASS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. LR-EVN-13.0 N81861

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| H| L| R| S