BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH

    MDR report key: 6633480 · Received June 12, 2017

    Report

    Report Number
    2522007-2017-00023
    Event Type
    Injury
    Date Received
    June 12, 2017
    Date of Event
    May 19, 2017
    Report Date
    November 20, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    UDI-DI
    00827002250840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G5-510(K) # K142301. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR A PHYSICAL EXAMINATION. X-RAYS AND PHOTOGRAPHS WERE PROVIDED AND REVIEWED. A VISUAL INSPECTION CONFIRMED THE SHEATH TIP HAD DISCONNECTED. THE SHEATH HAD UNEVEN SURFACES (BENDS) ON THE INNER AND OUTER DIAMETERS. THE WALL APPEARS TO HAVE BEEN BREACHED BY THE EVOLUTION TURNING ACTION BEING ENGAGED WHILE INSIDE THE SHEATH, AT ONE OF THE CURVES OR TURNS OF THE SHEATH CAUSING THE SHEATH WALL TO PEEL AWAY, AND THE TIP THEN PULLING OFF. THE SECTION THAT PEELED AWAY WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THIS LOT AND THERE WERE NO SIGNS THAT THE STEADY SHEATH WAS MANUFACTURED OUTSIDE OF SPECIFICATION AND THAT NONCONFORMING PRODUCT WAS RELEASED TO THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN INTENDED PACEMAKER LEAD EXTRACTION PROCEDURE TO REMOVE AND REPLACE A PREVIOUSLY DAMAGED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD MADE BY ANOTHER MANUFACTURER. THE PHYSICIAN USED A LEAD EXTRACTION STEADYSHEATH® EVOLUTION® TISSUE STABILIZATION SHEATH DURING THIS PROCEDURE. DUE TO HEAVILY CALCIFIED SCAR TISSUE, THE ICD LEAD BROKE. DURING THE ICD LEAD REMOVAL, THE METAL TIP OF THE LEAD EXTRACTION STEADYSHEATH® EVOLUTION® TISSUE STABILIZATION SHEATH BROKE OFF IN THE PATIENT¿S CLAVICLE. A NEW INTRODUCER WAS REQUIRED TO GAIN ACCESS TO THE PATIENT'S VASCULAR SYSTEM. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS UNABLE TO RETRIEVE THE BROKEN PIECE OF THE METAL TIP; THEREFORE IT WAS LEFT INSIDE THE PATIENT¿S BODY. AN ADDITIONAL PROCEDURE WILL BE NECESSARY TO REMOVE THE TIP FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415198 LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC N/A N141635 00827002250840

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R