BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16306876 · Received February 6, 2023

    Report

    Report Number
    2024168-2023-01228
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    January 17, 2023
    Report Date
    April 5, 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. THE ADDITIONAL PROGLIDE DEVICE WITH REPORTED ISSUE IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED CUFF MISS WAS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. 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: CORRECTION LOT# LOT NUMBER CHANGED FROM 2082542 TO 2021541.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED WITH THE FIRST PROGLIDE DEVICE. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO AN 18F; HOWEVER, TISSUE DAMAGE/ VESSEL DAMAGE OCCURRED WITH THE UPSIZED SHEATH. THE INTERVENTIONAL PROCEDURE WAS COMPLETED. AS A RESULT OF THE TISSUE DAMAGE, WHEN TIGHTENING THE KNOT OF ONE OF THE PROGLIDE DEVICES, THE KNOT SLIPPED AND WAS UNABLE TO BE TIGHTENED COMPLETELY [KNOT LOCK]. AN ADDITIONAL PROGLIDE SUTURE WAS DEPLOYED AND HEMOSTASIS OF THE LARGE HOLE WAS ACHIEVED WITH THE OTHER PRE-PLACED SUTURE AND THE POST PLACED SUTURE. THERE WAS NO REPORTED 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
    1225673 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2021541

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention