BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2644387 · Received July 2, 2012

    Report

    Report Number
    2522007-2012-00013
    Event Type
    Injury
    Date Received
    July 2, 2012
    Report Date
    June 28, 2012
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO INFO SUPPLIED TO TRACKWISE, THE PRODUCT ARE NOT BEING RETURNED FOR EVAL. PRODUCT NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PER COMPLAINT EMAIL: THE NEEDLE EYE SNARE PERFORATION THE VASCULATURE. LEAD: SJM RIATA RV-2008; REDUNDANT RV LEAD OF UNK MODEL TYPE; RA LEAD OF UNK MODEL TYPE. INJURY: VASCULAR TEAR OF UNK ORIGIN. INTERVENTION: STERNAL WINDOW PERFORMED IN EP LAB, PT THEN TRANSFERRED TO OPERATING ROOM FOR A COMPLETE STERNOTOMY; PT STATUS IN UNK. E-MAIL RECEIVED FROM KIM ''DONOGUE FROM DR. FREEDOM: "(B)(4): TAMPONADE DURING USE OF NES VIA FEMORAL VEIN. REQUIRED IMMEDIATE SUBXIPHOID INCISION FOR RESOLUTION. PT SUBSEQUENTLY UNDERWENT SURGICAL PLACEMENT OF EPICARDIAL PACING LEADS VIA SAME INCISION. PLACEMENT OF EPICARDIAL LEADS WAS ACTUALLY PLANNED AS PART OF PROCEDURE FROM THE START. LOCATION OF PERFORATION WAS NEVER IDENTIFIED, PRESUMABLY INTRAPERICARDIAL SVC, RA, OR RV. PT DID WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NONE DYB COOK VASCULAR INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention