BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18764330 · Received February 22, 2024

    Report

    Report Number
    2024168-2024-02307
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    January 31, 2024
    Report Date
    May 22, 2024
    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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, SUTURE PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ADDITIONAL PERCLOSE PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE BREAK COULD NOT BE TESTED DUE TO DEVICE COMPONENTS NOT BEING RETURNED. THERE WAS NO REPORT OF A FOOT DETACHMENT, FLOW DISTURBANCES OR PATIENT EFFECTS THAT WOULD SUGGEST THAT THE SEPARATED FOOT WAS LEFT BEHIND IN THE PATIENT. THEREFORE THE DETACHMENT LIKELY OCCURRED DUE TO POST PROCEDURAL HANDLING. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, SUTURE PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. CORRECTIONS: H3 - DEVICE RETURNING STATUS UPDATED FROM NO TO YES. H6 - TYPE OF INVESTIGATION CODE 4115 WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VESSEL CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED WITH FOUR PROGLIDE DEVICES. REPORTEDLY, THE SUTURE BROKE/FRAYED FOR ALL DEVICES. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED:A FOOT BREAK WAS FOUND DURING EVALUATION ONE OF OF THE RETURNED DEVICES (CN-213994). THE LOCATION OF THE DETACHED FOOT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237784 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3112342 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention