BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1220330 · Received November 4, 2008

    Report

    Report Number
    2953144-2008-01772
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    April 1, 2004
    Report Date
    October 10, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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: SUTURE PULLED OUT OF THE ARTERY. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: DEATH, CAUSE UNSPECIFIED. IT WAS REPORTED THAT IN THE SPRING OF 2004, A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY. THE PATIENT HAD BEEN ADMITTED WITH SEVERE UNSTABLE ANGINA AND UNDERWENT A DIAGNOSTIC CARDIAC CATHETERIZATION PROCEDURE. THE PATIENT EXPERIENCED A SMALL HEMATOMA AT THE GROIN SITE THAT WAS TREATED WITH MANUAL COMPRESSION FOR APPROXIMATELY 5 MINUTES, FOLLOWED BY A SANDBAG, BOTH OF WHICH ARE STANDARD POST-CLOSURE PROCEDURES AT THIS USER FACILITY. THE PHYSICIAN REPORTED THAT THE CLOSURE PROCEDURE WAS NO DIFFERENT THAN ANY OTHER CASE; NO UNUSUAL ISSUES WERE ENCOUNTERED. THE PATIENT HAD RECEIVED PLAVIX, INTREGRILIN AND HEPARIN AND THE HEMATOMA WAS ATTRIBUTED TO THE ANTICOAGULANTS. FIVE DAYS AFTER DISCHARGE, THE PATIENT PRESENTED WITH SYMPTOMS OF HYPOTENSION, PAIN AT THE GROIN ARTERIOTOMY SITE AND SHORTNESS OF BREATH. ULTRASOUND SHOWED A SMALL AMOUNT OF BLOOD AT THE GROIN SITE. THE BLOOD WAS EVACUATED VIA CUT DOWN AT WHICH TIME IT WAS NOTED THAT "THE SUTURE HAD PULLED OUT OF THE ARTERY" WITHIN THAT TIMEFRAME. THE PATIENT'S WHITE BLOOD CELL COUNT WAS ELEVATED; THERE WAS NO SIGN OF INFECTION AT THE GROIN SITE. THE PATIENT SYMPTOMS CONTINUED AND A CT SHOWED "A SMALL AMOUNT OF PRE-PERITONEAL AND A SMALL AMOUNT OF RETROPERITONEAL BLOOD". THE PATIENT WAS TAKEN TO SURGERY WHERE A 14CM X 14CM RETROPERITONEAL HEMATOMA WAS REMOVED. THE SOURCE OF THE RETROPERITONEAL BLOOD WAS REPORTED AS UNKNOWN. THE PATENT'S SHORTNESS OF BREATH WORSENED. SPECIFICS REGARDING THE ORIGIN OF HIS SYMPTOMS WERE NOT PROVIDED. THE PATIENT EVENTUALLY EXPERIENCED ADULT RESPIRATORY DISTRESS SYNDROME, REQUIRED INTUBATION AND EXPERIENCED RENAL FAILURE WHICH ULTIMATELY LED TO HIS DEATH 28 DAYS POST PROCEDURE. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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 62 YR Death HEPARIN| INTERGRILIN| PLAVIX