BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 7969212 · Received October 16, 2018

    Report

    Report Number
    2522007-2018-00026
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    November 26, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)# K142301. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED FOR A PHYSICAL INVESTIGATION. A DETERMINATION IF THE DEVICE WAS DEFECTIVE IS INCONCLUSIVE. THE INSTRUCTIONS FOR USE WAS REVIEWED AND LISTED AS POSSIBLE POTENTIAL ADVERSE EVENTS ARE: 'LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM/CARDIAC TAMPONADE'. THIS COMPLAINT EVENT IS A KNOWN FAILURE MODE AND WILL BE MONITORED PER THE COMPLAINT HANDLING AND POST MARKET PROCESSES. THE LOT NUMBER IS UNKNOWN AND THEREFORE THE DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. DATE OF EVENT: UNKNOWN; PRODUCT CODE: DRE. THE 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

    PER JOURNAL ARTICLE: "NEW TOOL TO OVERCOME LEAD FIBROUS BINDING SITES: A WORD OF CAUTION." DEVICE USED TO REMOVE 2 RV LEADS IMPLANTED. BOTH LEADS WERE SUCCESSFULLY REMOVED BUT A MASSIVE TRICUSPID REGURGITATION WAS DIAGNOSED BY TRANSTHORACIC ECHOCARDIOGRAPHY. IT WAS SUCCESSFULLY REPAIRED AND PATIENT WAS DISCHARGED SEVERAL DAYS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809524 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention