BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO GRAFT

    MDR report key: 3830060 · Received May 23, 2014

    Report

    Report Number
    3006945290-2014-00040
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 29, 2014
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    "DATE OF THIS REPORT", CORRECTED TO 04/29/2014. "DATE RECEIVED BY MANUFACTURER", CORRECTED TO 04/29/2014. MANUFACTURER NARRATIVE: ACCORDING TO THE REPORT, DURING THE SURGEONS FIRST CASE HE INDICATED HE WAS DISAPPOINTED WITH THE SHEATHS AND DILATORS (THE ACCESSORY KIT IN GENERAL). HE HAD DIFFICULTY USING THE SHEATHS AND CALLED THEM "ARCHAIC" AND CHEAP. THE SURGEON ASKED WHY CRYOLIFE STILL USED SUCH OUTDATED ITEMS. THE SHEATH CAUSED DAMAGE TO THE INNER LUMEN OF THE JUGULAR VEIN ENTERING THE SUPERIOR VENA CAVA. HE USED THE INCLUDED DILATORS AS WELL AS A TERUMO "DESTINATION" SHEATH AND AN 8F X 4CM BALLOON TO GAIN ACCESS TO THE RIGHT ATRIUM. THE MANUFACTURING RECORDS FOR LOT H13AK016 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE HERO GRAFT INSTRUCTIONS FOR USE (IFU) LISTS TRAUMA TO MAJOR VASCULATURE AS A POTENTIAL COMPLICATION AND GIVES DIRECTIONS AS TO PROPER USE OF THE SHEATH, "INSERT THE SHORT 20F INTRODUCER FROM THE ACCESSORY COMPONENT KIT OF THE GUIDEWIRE. THE LONG 20F INTRODUCER MAY BE USED IF NEED FOR ATYPICAL ACCESSES. NOTE: USE OF THE SHORTER INTRODUCER MAY HELP PREVENT KINKING SINCE IT CANNOT BE ADVANCED AS FAR INTO THE VESSEL." A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN PERFORMED. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, DURING THE SURGEONS FIRST CASE HE INDICATED HE WAS DISAPPOINTED WITH THE SHEATHS AND DILATORS (THE ACCESSORY KIT IN GENERAL). HE HAD DIFFICULTY USING THE SHEATHS AND CALLED THEM "ARCHAIC" AND CHEAP. THE SURGEON ASKED WHY CRYOLIFE STILL USED SUCH OUTDATED ITEMS. THE SHEATH CAUSED DAMAGE TO THE INNER LUMEN OF THE JUGULAR VEIN ENTERING THE SUPERIOR VENA CAVA. HE USED THE INCLUDED DILATORS AS WELL AS A TERUMO "DESTINATION" SHEATH AND AN 8F X 4CM BALLOON TO GAIN ACCESS TO THE RIGHT ATRIUM.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, DURING THE SURGEONS FIRST CASE, HE INDICATED HE WAS DISAPPOINTED WITH THE SHEATHS AND DILATORS (THE ACCESSORY KIT IN GENERAL). HE HAD DIFFICULTY USING THE SHEATHS AND CALLED THEM "ARCHAIC" AND CHEAP. THE SURGEON ASKED WHY CRYOLIFE STILL USED SUCH OUTDATED ITEMS. THE SHEATH CAUSED DAMAGE TO THE INNER LUMEN OF THE JUGULAR VEIN ENTERING THE SUPERIOR VENA CAVA. HE USED THE INCLUDED DILATORS AS WELL AS A TERUMO "DESTINATION" SHEATH AND AN 8F X 4CM BALLOON TO GAIN ACCESS TO THE RIGHT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308755 HERO GRAFT VASCULAR GRAFT DSY HEMOSPHERE, INC. HERO 1003 H13AK016

    Patients

    Seq Age Sex Outcome Treatment
    1 Other