BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 13261765 · Received January 14, 2022

    Report

    Report Number
    2024168-2022-00533
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    December 17, 2021
    Report Date
    March 4, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    SUBSEQUENT TO THE INITIAL MDR FILED, IT WAS DETERMINED THIS EVENT IS A DUPLICATE OF AN INCIDENT THAT WAS PREVIOUSLY REPORTED UNDER MFR # 2024168-2022-2022-00327-00. ALL EVENT INFORMATION IS CONSERVED IN MFR# 2024168-2022-2022-00327-01.B5: DESCRIBE EVENT OR PROBLEM DEVICE RETURNING UNDER MFR # 2024168-2022-2022-00327-01. MEDICAL DEVICE PROBLEM CODE 2921 REMOVED. HEALTH EFFECT - CLINICAL CODE 4559, 1884 REMOVED. HEALTH EFFECT - IMPACT CODE 4641 REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER A LEFT-SIDE TRANSFEMORAL CAROTID STENTING PROCEDURE. REPORTEDLY, WHEN DEPLOYING, THE FOOTPLATE DID NOT RETRACT AND MADE THE ACCESS SITE SLIGHTLY LARGER. THE DEVICE APPROPRIATELY CAPTURED BOTH ENDS OF THE ARTERIOTOMY, HOWEVER, IT DID NOT FULLY CLOSE AND CAUSED SLIGHT DILATATION OF THE ARTERIOTOMY. THIS REQUIRED APPLICATION OF MANUAL PRESSURE DUE TO A SMALL HEMATOMA. MANUAL SUTURING REPAIRED THE SLIGHTLY LARGER ACCESS SITE AND ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR FILED, IT WAS DETERMINED THIS EVENT IS A DUPLICATE OF AN INCIDENT THAT WAS PREVIOUSLY REPORTED UNDER MFR # 2024168-2022-2022-00327-00. ALL EVENT INFORMATION IS CONSERVED IN MFR# 2024168-2022-2022-00327-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626454 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 1111141 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention