BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1200004 · Received October 16, 2008

    Report

    Report Number
    2953144-2008-01693
    Event Type
    Death
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 22, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 MALFUNCTION: NONE. SYMPTOMS/AE: HEMATOMA, RETROPERITONEAL BLEED, DEATH. TIME OF SYMPTOMS/AE: AFTER VESSEL CLOSURE. IT WAS REPORTED THAT A TECH TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF A CALCIFIED FEMORAL ARTERY AFTER AN EMERGENT CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, A SMALL HEMATOMA, OF AN UNSPECIFIED SIZE, DEVELOPED AFTER THE PROCEDURE. NO TREATMENT WAS PROVIDED. THE PROGLIDE FUNCTIONED NORMALLY AND ACHIEVED HEMOSTASIS. LATER THAT EVENING THE PT BEGAN TO EXPERIENCE SYMPTOMS OF HYPOTENSION AND ABDOMEN PAIN. A RETROPERITONEAL BLEED WAS SUSPECTED. AN EXPLORATORY ANGIOGRAM WAS UNSUCCESSFUL IN LOCATING THE SITE OF THE BLEED. THERE WAS NO CONTRAST EXTRAVASATION VISUALIZED AT THE PUNCTURE SITE. THE BLEED WAS NOT SURGICALLY TREATED. THE PT WAS TREATED WITH 20UNITS OF BLOOD AND 8UNITS OF PLASMA. THE PT EXPIRED 24 HOURS AFTER THE PROCEDURE. REPORTEDLY, THE RETROPERITONEAL BLEED WAS NOT CAUSED BY THE PROGLIDE OR FROM THE INTERVENTIONAL CORONARY PROCEDURE. THE BLEED WAS THE RESULT OF LARGE QUANTITY OF ANTICOAGULANTS. 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 - REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death INTEGRILIN| 7FR SHEATH