BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1960092 · Received January 13, 2011

    Report

    Report Number
    2024168-2011-00277
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF NINE RETURNED STERILE DEVICES WERE FUNCTIONALLY TESTED. THE NEEDLE DEPLOYMENT, SUTURE RETRIEVAL AND KNOT ADVANCEMENT WERE ALL SUCCESSFUL. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS; THEREFORE, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. ADDITIONALLY, NINE UNUSED REPRESENTATIVE SAMPLE DEVICES WITH THE SAME PART/LOT NUMBER RELATED TO THIS PRODUCT EXPERIENCE ARE EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) OPERATOR NOT TRAINED BY AN ABBOTT VASCULAR REPRESENTATIVE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. ADDITIONALLY, NINE UNUSED REPRESENTATIVE SAMPLE DEVICES WITH THE SAME PART/LOT NUMBER RELATED TO THIS PRODUCT EXPERIENCE ARE EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN UNTRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, "THE PHYSICIAN PULLED THE BLUE RAIL SUTURE LIMB IN ORDER TO CLOSE WITH THE SUTURE, BUT THE BLUE RAIL EXITED TOTALLY FROM THE SKIN." MANUAL COMPRESSION WAS APPLIED FOR 15 MINUTES TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PATIENT ADVERSE EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 930436H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORDIS AVANTI PLUS 6F, HEPARIN 7000 UNITS