BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 6395438 · Received March 10, 2017

    Report

    Report Number
    2522007-2017-00011
    Event Type
    Death
    Date Received
    March 10, 2017
    Date of Event
    January 25, 2017
    Report Date
    December 15, 2017
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SENT UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    510(K): K141148. EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SECTION A: PATIENT AGE AT TIME OF EVENT - THE PATIENT WAS REPORTED TO BE IN HER 80'S. INVESTIGATION ¿ EVALUATION. THE LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET WAS NOT RETURNED FOR A PHYSICAL INVESTIGATION. NO PHOTO'S OR X-RAYS WERE PROVIDED FOR REVIEW/ANALYSIS A REVIEW OF COMPLAINT HISTORY AND TRENDS WAS PERFORMED. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE. DURING THE LEAD EXTRACTION, THE PATIENT EXPIRED. THE STAFF PERFORMED RESUSCITATION FOR OVER AN HOUR; EXTRACORPOREAL CARDIOPULMONARY RESUSCITATION WAS PERFORMED BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PATIENT'S CHEST WAS NOT CRACKED OPEN. NO FURTHER INFORMATION WAS PROVIDED. SEE SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176506 LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death