BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 5063617 · Received September 9, 2015

    Report

    Report Number
    1820334-2015-00573
    Event Type
    Injury
    Date Received
    September 9, 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. EVENT EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION; HOWEVER, A REVIEW OF THE COMPLAINT HISTORY AND DEVICE HISTORY RECORD WAS CONDUCTED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MANUFACTURED TO SPECIFICATION. THERE IS NO INFORMATION TO SUGGEST THE DEVICE MALFUNCTIONED OR CONTAINED A NONCONFORMITY. WORK ORDERS WERE REVIEWED, AND NO EVIDENCE OF NONCONFORMITY WAS FOUND. COMPLAINTS WERE REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN FILED AGAINST DEVICES FROM THESE LOTS. BECAUSE THE DEVICES WERE NOT RETURNED, NO IMAGES WERE PROVIDED, AND FEW DETAILS OF THE PROCEDURE WERE PROVIDED, THE ROOT CAUSE OF THE COMPLAINT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    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. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596500 LEAD EXTRACTION EVOLUTION SHORTIE 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