BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 7171523 · Received January 8, 2018

    Report

    Report Number
    2522007-2018-00001
    Event Type
    Injury
    Date Received
    January 8, 2018
    Date of Event
    December 12, 2017
    Report Date
    August 17, 2018
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    UDI-DI
    10827002237473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # - K141148. INVESTIGATION SUMMARY: THE AFFECTED PRODUCT WAS NOT RETURNED FOR THIS COMPLAINT AND THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE INSTRUCTIONS FOR USE WAS REVIEWED AND LISTED AS A POTENTIAL ADVERSE EVENT IS 'LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM'. THIS COMPLAINT EVENT IS A KNOWN FAILURE MODE AND WILL BE MONITORED AND TRENDED THROUGH THE COMPLAINT HANDLING AND POST MARKET PROCESSES. A 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. THIS COMPLAINT COULD ONLY BE CONFIRMED THROUGH CUSTOMER TESTIMONY.

    Description of Event or Problem · 0

    SEE ADDITIONAL MFR NARRATIVE FOR THE INVESTIGATION OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PMA/510(K) # - K141148. DEVICE - THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE COURSE OF THE LEAD EXTRACTION PROCEDURE, A SMALL BLEED OCCURRED IN A MINOR BRANCH OF THE INNOMINATE VEIN. INTERVENTION WAS REQUIRED IN THE FORM OF A CHEST DRAIN AND BOTH LEADS WERE EXTRACTED SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, AFTER PUTTING THE DRAIN IN AND CONTINUING WITH THE LEAD EXTRACTION, "PATIENT IS FINE." THE LEADS HAD BEEN IMPLANTED FOR OVER 17 YEARS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16236 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. 10827002237473

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention