BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH

    MDR report key: 7178237 · Received January 10, 2018

    Report

    Report Number
    2522007-2018-00002
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    December 12, 2017
    Report Date
    January 8, 2019
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    UDI-DI
    00827002250840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE DRE. 510(K)# K142301. DEVICE CODE DESC CHANGED TO ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM (2993). EC METHOD CODE CHANGED TO DEVICE NOT RETURNED (4114). EC RESULTS CODE DESC CHANGED TO NO FINDINGS AVAILABLE (3221). EC CONCLUSIONS CODE DESC 1 CHANGED TO KNOWN INHERENT RISK OF DEVICE (22). SUMMARY OF INVESTIGATION: THE LR-TSS-13.0 DEVICE WAS NOT RETURNED FOR THIS COMPLAINT INVESTIGATION, THEREFORE NO PHYSICAL INVESTIGATION BY THE QUALITY ENGINEERING AND ENGINEERING DEPARTMENTS WAS PERFORMED. NO PHOTO'S OR X-RAYS WERE PROVIDED. THE DEVICE WAS NOT RETURNED, THEREFORE A DETERMINATION IF THE DEVICE WAS DEFECTIVE IS INCONCLUSIVE. THE IFU WAS REVIEWED, AND LISTED IN THE IFU 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 VIA THE COMPLAINT HANDLING AND POST MARKET PROCESSES AT CVI. A RISK ASSESSMENT WAS CONDUCTED AND IT WAS DETERMINED THAT NO FURTHER RISK REDUCTION IS NECESSARY. A DEVICE HISTORY RECORD REVIEW FOR THIS LOT NUMBER-N141080 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 REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    SEE H10 FOR INVESTIGATION OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH MANUFACTURER REPORT # 2522007-2018-00001. (B)(4). THE 510(K) # - K142301. 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
    22749 LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC G25084 N141080 00827002250840

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention