BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 7991007 · Received October 22, 2018

    Report

    Report Number
    2522007-2018-00022
    Event Type
    Injury
    Date Received
    October 22, 2018
    Report Date
    February 13, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D 2B-PRODUCT CODE: DRE. SECTION G 5-PMA/510(K)#: K142301. INVESTIGATION SUMMARY: NO LR-EVN DEVICE WAS RETURNED TO CVI. THIS COMPLAINT WAS ISSUED DUE TO A LITERATURE REVIEW, FROM THE LIBIN CARDIOVASCULAR INSTITUTE OF ALBERTA, UNIVERSITY OF CALGARY, CALGARY ALBERTA CANADA. THE DEVICE WAS NOT RETURNED TO CVI THEREFORE A PHYSICAL INVESTIGATION OF THE DEVICE WAS NOT PERFORMED. THE QUALITY ENGINEERING DEPARTMENT REVIEWED THE PROVIDED ARTICLE. A MANUFACTURING FAILURE/DEFECT OF THE DEVICE COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. ADVERSE PHYSIOLOGICAL RESPONSE IS A KNOWN FAILURE MODES OF THIS DEVICE. LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM IS ALSO LISTED AS A POTENTIAL ADVERSE EVENT IN THE INSTRUCTIONS FOR USE. THIS COMPLAINT WILL BE MONITORED AND TRENDED THROUGH THE CVI COMPLAINT HANDLING AND THE POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED VIA A QERA AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB OF TRACKWISE. THE DHR COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNKNOWN/NOT PROVIDED. 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 A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE INITIAL REPORT WAS FILED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. PMA/510(K)#: K142301. 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: 'CENTRAL VENOUS CATHETER FRACTURE DURING PACEMAKER LEAD EXTRACTION', "IN THIS CASE REPORT, WE PRESENT AN UNUSUAL AND POTENTIALLY LIFE-THREATENING COMPLICATION OF LEAD EXTRACTION, IN WHICH A CVC COURSING IPSILATERALLY TO THE PACEMAKER LEADS WAS FRACTURED DURING THE USE OF MECHANICAL SHEATHS. THE CATHETER EMBOLIZED DISTALLY INTO THE RIGHT ATRIUM. THE POLYURETHANE CATHETER WAS LIKELY DAMAGED INTRAOPERATIVELY DIRECTLY BY THE USE OF THE LASER AND EVOLUTION MECHANICAL EXTRACTION SHEATHS. TO OUR KNOWLEDGE, SUCH A COMPLICATION HAS NOT BEEN REPORTED PREVIOUSLY IN THE SCIENTIFIC LITERATURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831732 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 6F GOOSENECK-TYPE SNARE| 6F GOOSENECK-TYPE SNARE| 6F GOOSENECK-TYPE SNARE