BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 7991486 · Received October 22, 2018

    Report

    Report Number
    2522007-2018-00025
    Event Type
    Injury
    Date Received
    October 22, 2018
    Report Date
    November 26, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K142301. INVESTIGATION SUMMARY: THE COMPLAINT WAS INITIATED FROM A LITERATURE REVIEW. THE COMPLAINT DEVICE WAS NOT AVAILABLE AND THEREFORE NOT RETURNED FOR A PHYSICAL INVESTIGATION. A SPECIFIC DEVICE WAS NOT ASSIGNED TO THIS COMPLAINT. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS NO LOT NUMBERS WERE PROVIDED. THIS IS A KNOWN COMPLAINT MODE AND WILL BE MONITORED PER THE COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCESSES.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. PMA/510(K)#: K142301. 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

    PER JOURNAL ARTICLE: "REMOVAL OF ACTIVE-FIXATION CORONARY SINUS LEADS USING A MECHANICAL ROTATION EXTRACTION DEVICE"; 'IMMEDIATELY AFTER LEAD EXTRACTION, 1 PATIENT DEVELOPED PERICARDIAL TAMPONADE AND REQUIRED SURGICAL INTERVENTION. AFTER ESTABLISHMENT OF CARDIOPULMONARY BYPASS, A 5-MM SHARP CUT IN THE LATERAL VEIN OF THE CORONARY SINUS WAS IDENTIFIED. THE LESION WAS FIXED AND THE PATIENT SURVIVED.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833258 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention