BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2032897 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02129
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WHOLE MONOFILAMENT WAS RETURNED LOOSE AND NO SIGN OF BREAKAGE AS REPORTED. THE POSTERIOR CUFF AND NEEDLE TIP WERE ATTACHED TO THE RAIL END. THE LINK WAS STILL ATTACHED TO THE POSTERIOR CUFF AND THE ANTERIOR END WAS CLEAN CUT. SINCE THE MONOFILAMENT WAS RETURNED INTACT, THE CONDITION OF THE RETURNED DEVICE DOES NOT MATCH THE COMPLAINT DESCRIPTION. THEREFORE THE CAUSE FOR THIS REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD 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 PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING KNOT ADVANCEMENT, EXCESSIVE PRESSURE WAS APPLIED ON THE SUTURE AND THE SUTURE BROKE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 960306H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention