BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2981333 · Received February 27, 2013

    Report

    Report Number
    2024168-2013-01151
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 5, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED DATE OF OCCURRENCE, EVENT REPORTEDLY OCCURRED APPROXIMATELY TWO WEEKS BEFORE REPORTING, EXACT DATE NOT REMEMBERED. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR INVESTIGATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER SUCCESSFUL DEPLOYMENT OF THE SUTURE, THE KNOT WAS ADVANCED BUT HEMOSTASIS WAS NOT ACHIEVED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ATTEMPT HEMOSTASIS. THE PATIENT WAS TAKEN TO THE CRITICAL CARE UNIT WITH MANUAL ARTERIAL COMPRESSION STILL BEING APPLIED. THE PATIENT EXPIRED THAT DAY WHILE IN THE CRITICAL CARE UNIT. THE REPORTER THOUGHT THERE WAS A POSSIBLE VESSEL DISSECTION, BUT WAS NOT SURE WHAT CAUSED IT. IT WAS ASKED IF THERE WAS A POSSIBLE RETROPERITONEAL BLEED BUT NO ONE RECALLED THE PHYSICIAN MENTIONING IT. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84450 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death