BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK EVOLUTION MECHANICAL DILATOR SHEATH

    MDR report key: 2161932 · Received July 11, 2011

    Report

    Report Number
    1721279-2011-00043
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    COOK MEDICAL
    Product Code
    DRE
    PMA / PMN Number
    K061000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD PRESSURE WAS BEING TREATED BY THE ANESTHESIOLOGIST. THE SURGEON PERFORMED A STERNAL WINDOW AND FOUND NO PERICARDIAL BLEEDING. IT WAS AT THIS TIME THE CT SURGEON DECIDED TO PERFORM A CUT DOWN AND REPAIRED A SMALL TEAR IN THE SUBCLAVIAN VEIN. THE PATIENT'S PRESSURE STABILIZED, THE MD RETURNED TO THE 16F SLS II AND SUCCESSFULLY REMOVED THE LEADS. NO DEVICES WERE RETAINED FOR RETURN ENGINEERING ANALYSIS. SEVERAL UNSUCCESSFUL ATTEMPTS ((B)(6) 2011) WERE MADE TO OBTAIN LOT INFORMATION. THERE IS NO REPORTED INFORMATION THAT SUGGESTS THE SPNC DEVICE(S) DID NOT PERFORM AS INTENDED OR CAUSED THE PATIENT'S INJURY. THE MD STATED HE FELT IT "COULD HAVE BEEN THE EVOLUTION" THAT CAUSED THE VESSEL INJURY. PATIENT STATUS UPDATE: ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT HAD SUCCUMB TO ACUTE, SEVERE SEPSIS. THE MD STATED THE PATIENT'S CAUSE OF DEATH WERE COMPLICATIONS DUE TO SEPSIS AND WERE COMPLETELY UNRELATED TO THE LASER LEAD EXTRACTION.

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE CONDUCTED IN THE OPERATING ROOM TO REMOVE AN ICD SYSTEM DUE TO AN ACUTE INFECTION. THIS PATIENT WAS TRANSFERRED TO THIS FACILITY BECAUSE OF THE SEVERITY OF THE INFECTION AND THE PATIENT'S PRE-MORBIDITIES. THE SYSTEM WAS IMPLANTED IN 2008, CONSISTING OF 2 LEADS (RA AND RV). CT SURGEON WAS SCRUBBED IN TO CASE, ARTERIAL LINE PLACED, FLUOROSCOPY AND TEE IN USE. THE MD PREPPED BOTH LEADS WITH A COOK "LIBERATOR" LOCKING DEVICE, A "BULLDOG" LEAD EXTENDER AND BEGAN LASING THE RV LEAD WITH THE 14F SLS II. THE MD NOTED THAT BOTH LEADS WERE IMPLANTED VIA THE SAME VESSEL. PROGRESSION STOPPED AT THE INNOMINATE VEIN/SVC JUNCTION, THE MD CHOSE TO UPSIZE TO THE 16F SLS II BUT WAS UNABLE TO PROGRESS FURTHER STILL. FOCUS WAS THEN SWITCHED TO THE RA LEAD WITH THE SAME RESULT. THE MD REMOVED THE LASER SHEATH AND ASKED FOR A 13F COOK EVOLUTION. THE EVOLUTION WAS INSERTED, POSITIONED 2-3 TIMES AND ULTIMATELY REMOVED WHEN THE MD DID NOT FEEL AS THOUGH IT WAS THE CORRECT DEVICE FOR THE SPECIFIC ANATOMY. AT THIS TIME, A MODERATE AMOUNT OF BLOOD WAS EXUDING FROM THE OPEN POCKET AND THE PATIENT'S ARTERIAL BLOOD PRESSURE WAS DECLINING SLOWLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK EVOLUTION MECHANICAL DILATOR SHEATH 13F EVOLUTION DRE COOK MEDICAL G46541 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R 14F SLS: (B)(4)| CVX-300 EXCIMER LASER: (B)(4)| 2 COOK LIBERATOR LOCKING STYLETS: (B)(4)| 2 COOK BULLDOG EXTENDERS: (B)(4)| 16F SLS II: (B)(4)