BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CLOSER S 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1083434 · Received July 29, 2008

    Report

    Report Number
    2953144-2008-01249
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    August 23, 2001
    Report Date
    July 15, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. THE DEVICE WAS AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBER WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: RANDOLPH L GEARY, MD ET AL; "INFECTION IS AN UNUSUAL BUT SERIOUS COMPLICATION OF A FEMORAL ARTERY CATHETERIZATION SITE CLOSURE DEVICE". ANN VASC SURG 2001; 15:567-570.

    Description of Event or Problem · 1

    SYMPTOMS/AE: INFECTED ACCESS SITE PSEUDOANEURYSM TREATED WITH DEBRIDEMENT AND VEIN PATCH. TIME OF SYMPTOMS/AE: 28 DAYS AFTER VESSEL CLOSURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW THAT 803 PTS UNDERWENT DIAGNOSTIC CORONARY ANGIOGRAPHY FOLLOWED BY ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY (CFA) WITH THE CLOSER S DEVICE. THE PT WAS RE-ADMITTED WITH POST-SPLENECTOMY SEPSIS AND NEW-ONSET OF ATRIAL FIBRILLATION SEVEN DAYS AFTER VESSEL CLOSURE WITH A 6 FR CLOSER S DEVICE. AFTER THE INITIAL PROCEDURE, THE PT WAS TRANSFERRED TO A REHABILITATION FACILITY CENTER AND WAS NOTED TO HAVE INTERMITTENT DISCHARGE FROM HER CATHETERIZATION SITE. AFTER 3 WEEKS, WORSENING DRAINAGE PROMPTED A SURGICAL CONSULTATION WHERE AN INFECTED PSEUDOANEURYSM CAUSED BY S AUREUS WAS NOTED RESULTING IN DEBRIDEMENT OF THE CFA AND VEIN PATCH. THE PT REMAINED HOSPITALIZED FOR TWENTY-TWO DAYS AND WAS DISCHARGED WITH ANTIBIOTIC THERAPY FOR FORTY-TWO DAYS. THE PT WAS REPORTED TO BE ALIVE AND WELL 16 MONTHS POST-PROCEDURE. THE ARTICLE DOES NOT DESCRIBE THE STERILE TECHNIQUE USED FOR THE VESSEL CLOSURE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE CLOSER S 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R SHEATH: 6FR