BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 7939958 · Received October 5, 2018

    Report

    Report Number
    2522007-2018-00020
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    September 13, 2018
    Report Date
    November 21, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)# 141148. (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED FOR A PHYSICAL INVESTIGATION. NO PHOTOS OR X-RAYS WERE PROVIDED. A DETERMINATION IF THE DEVICE WAS DEFECTIVE IS INCONCLUSIVE. THE INSTRUCTIONS FOR USE WAS REVIEWED AND LISTED AS A POTENTIAL ADVERSE EVENT IS 'LACERATION OR TEARING OF THE VASCULAR STRUCTURES OR THE MYOCARDIUM'. THIS COMPLAINT EVENT IS A KNOWN FAILURE MODE AND WILL BE MONITORED PER THE COMPLAINT HANDLING AND POST MARKET PROCESSES. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED INCLUDING THE MANUFACTURING AND QUALITY CONTROL RECORDS. ALL STEPS WERE DOCUMENTED PER PROCEDURE, BY TRAINED PERSONNEL AND THERE WERE NO SIGNS TO INDICATE THAT A NONCONFORMING DEVICE WAS RELEASED TO THE FIELD.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE - DRE. (B)(6). PMA/510(K)# 141148. THIS EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS: THE PATIENT, (B)(6) YEAR OLD FEMALE UNDERWENT A PROCEDURE TO REMOVE TWO PACEMAKER LEADS THAT HAD BEEN IMPLANTED IN (B)(6) 1996. THE PHYSICIAN PREPPED WITH LLDE LOCKING STYLET X2. TOOK THE 13FR EVOLUTION AND STARTED AT THE RIGHT VENTRICLE OVER TO GET TO THE LEAD. IT WAS NOTED THE PATIENT HAD A LOT OF CALCIFICATION. PATIENT'S BLOOD PRESSURE DROPPED TO 60/30 (60 OVER 30). THE PHYSICIAN THEN INFLATED THE BALLOON AND BLOOD PRESSURE WENT UP TO 133/60 (ONE HUNDRED THIRTY THREE OVER 60). THE SURGEON OPENED THE PATIENT AND REPAIRED A SMALL HOLE IN THE RIGHT ATRIUM; WHICH WAS PAPER THIN LIKE TISSUE. AND THE SURGEON ALSO REMOVED THE LEADS SURGICALLY. WHEN THE LEADS WERE REMOVED SURGEON TURNED THE BY-PASS MACHINE OFF. AS OF THE DAY THIS INFORMATION WAS REPORTED THE PATIENT WAS STILL STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778298 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention