BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1659694 · Received April 13, 2010

    Report

    Report Number
    2953144-2010-00630
    Event Type
    Death
    Date Received
    April 13, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 19, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: HEMATOMA AND DEATH. ONSET OF ADVERSE EVENT: DURING VESSEL CLOSURE AND POST PROCEDURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ON (B) (6) 2010, TWO DRUG ELUTING STENTS (DES) WERE IMPLANTED IN THE RCA SUCCESSFULLY. NO RESISTANCE OR DIFFICULTY WAS NOTED DURING THE ARTERIOTOMY CLOSURE. AFTER THE SUTURES WERE DEPLOYED AND THE VESSEL CLOSURE WAS COMPLETED, THE PHYSICIAN OBSERVED BLEEDING AT THE PUNCTURE SITE. A FEMOSTOP WAS APPLIED TO COMPLETE HEMOSTASIS. THE PT DEVELOPED A VERY LARGE HEMATOMA AT THE PUNCTURE SITE. NO RETROPERITONEAL HEMORRHAGE, ANEMIA OR HEMODYNAMIC SHOCK WAS REPORTED. LATER IN THE AFTERNOON ON (B) (6) 2010, THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A SURGICAL PROCEDURE. THE SURGICAL PROCEDURE WAS TO TREAT THE PUNCTURE SITE (HEMATOMA AND VESSEL DAMAGED). THE PT DIED ON THE MORNING OF (B) (6) 2010. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| R SHEATH: INTRODUCER 6F