BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1951076 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00046
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 7, 2010
    Report Date
    December 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS RETURNED WITH ALL COMPONENTS IN PRE-DEPLOYED POSITION. DURING LAB TESTING, THE LUMINAL MARKING TEST FAILED AS REPORTED. THE DEVICE WAS DISASSEMBLED AND FOUND EXCESSIVE DRIED BLOOD AND OTHER BIOLOGICAL MATTERS OCCLUDING THE MARKER LUMEN. THE PROBABLE ROOT CAUSE FOR THE BLOCKED MARKER LUMEN IS DUE TO BLOOD CLOT OR OTHER BIOLOGICAL MATTERS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE NON-CALCIFIED, NOT TORTUOUS COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, ARTERIAL BACK FLOW THROUGH THE MARKER LUMEN WAS NOT OBSERVED; THE DEVICE WAS REMOVED AND ANOTHER PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT. 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 890016H

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention