BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16103073 · Received January 5, 2023

    Report

    Report Number
    2024168-2023-00155
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 15, 2022
    Report Date
    March 8, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE SUTURE MATERIAL SEPARATION WAS CONFIRMED AS A LINK SEPARATION. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE CAUSE OF THE REPORTED DIFFICULTY AND THE SUBSEQUENT TREATMENT ARE DUE TO THE CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, IT IS LIKELY, THE SEPARATION IS RELATED TO AN INTERACTION OF THE DEVICE WITH THE SUTURE PULLED UNTIL IT BREAKS, OR TENSIONING ANGLE IS NOT BEING COAXIAL. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D4: LOT NUMBER CHANGED FROM 2101141 TO 0112541.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING A PROGLIDE AFTER A CAROTID INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, WHEN REMOVING THE PLUNGER IT WAS NOTED THAT THE SUTURE BROKE. ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644490 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 0112541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention