BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 7003115 · Received November 6, 2017

    Report

    Report Number
    2522007-2017-00033
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 12, 2017
    Report Date
    March 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 · 1

    PRODUCT CODE: DRE, DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION. 510(K): K141148. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K): K141148. INVESTIGATION SUMMARY: THE AFFECTED PRODUCT WAS NOT RETURNED FOR PHYSICAL EXAMINATION. NO PHOTOGRAPHS WERE PROVIDED. THE COMPLAINT COULD ONLY BE CONFIRMED THROUGH CUSTOMER TESTIMONY. THE INSTRUCTIONS FOR USE WERE REVIEWED AND LISTED AS A POTENTIAL ADVERSE EVENT IS 'LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM'. NO LOT NUMBER WAS PROVIDED, THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE APPROPRIATE PERSONNEL WERE NOTIFIED AND THE COMPLAINT WILL BE LOGGED AND TRACKED IN THE COMPLAINT HANDLING PROCESS. THE DEVICE WAS NOT RETURNED, THEREFORE A DETERMINATION IF THE DEVICE WAS DEFECTIVE IS INCONCLUSIVE.

    Description of Event or Problem · 1

    THE AREA REPRESENTATIVE REPORTED THAT ON (B)(6) 2017, A LIBERATOR LOCKING STYLET WAS BEING USED FOR TRACTION ON A (B)(6)-YEAR-OLD, FEMALE PATIENT ALONG WITH A 16 FRENCH LASER. THE LIBERATOR GOT STUCK ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD. A LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET WAS THEN USED TO FREE IT UP. THEY WENT BACK TO USING THE LASER. WHEN THE LEAD WAS REMOVED THE PATIENT¿S BLOOD PRESSURE DROPPED. THE OR STAFF TRIED TO DO A PERICARDIOCENTESIS AND TRIED TO PUT UP A BRIDGE BALLOON BUT IT DID NOT HELP. THE SURGEON THEN OPENED THE PATIENT'S CHEST. THE HEART TISSUE SURROUNDING THE TEAR SEALED ITSELF UP AND THE BLEEDING STOPPED. THIS EVENT LED TO PROLONGED HOSPITALIZATION AND A SECOND PROCEDURE ON (B)(6) 2017 TO IMPLANT A SUBCUTANEOUS ICD. ON (B)(6) 2017, THE PATIENT WAS REPORTED TO BE STABLE AND REMAINED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782306 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE COOK VASCULAR INC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention