BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 5062319 · Received September 8, 2015

    Report

    Report Number
    1820334-2015-00572
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 13, 2015
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # K061000. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # K061000 EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY AND THE DEVICE HISTORY RECORD WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, INFORMATION WAS PROVIDED THAT AN EMERGENCY PROCEDURE STOPPED THE BLEEDING WHEN THE PATIENT'S SUBCLAVIAN VEIN WAS TORN. THE PATIENT SURVIVED WITH NO INDICATION OF LONG-TERM HEALTH EFFECTS. THE DEVICE OR EVENT THAT CAUSED THE BLEEDING IS UNKNOWN. THERE IS NO INFORMATION TO SUGGEST THE DEVICE MALFUNCTIONED OR CONTAINED A NONCONFORMITY. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MANUFACTURED TO SPECIFICATION. AS THE COMPLAINT DEVICES WERE NOT RETURNED, NO IMAGES WERE PROVIDED, AND FEW DETAILS OF THE PROCEDURE WERE PROVIDED; THEREFORE, WE ARE UNABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE DIFFICULTY EXPERIENCED. HOWEVER, DUE TO THE NATURE OF LEAD EXTRACTION SURGERY, A DEVICE CAN FUNCTION NORMALLY AND STILL CAUSE A TEAR IN A BLOOD VESSEL. WE WILL CONTINUE TO MONITOR THIS DEVICE. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA), NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING LEAD EXTRACTION OF A RV LEAD, THE SUBCLAVIAN VEIN WAS TORN. THE PATIENT WAS PUT ON BYPASS AND UNDERWENT OPEN CHEST SURGERY TO REPAIR DAMAGE TO THE SUBCLAVIAN VEIN AND SVC.

    Description of Event or Problem · 1

    DURING LEAD EXTRACTION OF A RV LEAD, THE SUBCLAVIAN VEIN OF THE (B)(6) FEMALE PATIENT WAS TORN. THE PATIENT WAS PUT ON BYPASS AND UNDERWENT OPEN CHEST SURGERY TO REPAIR DAMAGE TO THE SUBCLAVIAN VEIN AND SVC. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593248 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR