BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 10887046 · Received November 23, 2020

    Report

    Report Number
    2024168-2020-09823
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    October 29, 2020
    Report Date
    May 5, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY THE SUTURE TRIMMER AND CUT PORTION OF SUTURE WERE RETURNED. ANALYSIS WAS PERFORMED ON THE RETURNED GATED SUTURE TRIMMER. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT PROVIDED. IN THE ABSENCE OF DEVICE OR POSTERIOR NEEDLE TIP RETURNED FOR ANALYSIS A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. 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.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE TWO PROGLIDES USED IN THIS CASE HAD DIFFERENT LOT#S (0051041 AND 0050742); HOWEVER, IT IS UNKNOWN WHICH LOT# BELONGED TO THE COMPLAINT DEVICE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH TWO PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 7F SHEATH PRIOR TO A PLUGGING OF INTERNAL ILIAC ARTERY INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SUTURE OF THE TWO PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH SIZE WAS UPSIZED TO 14F AND THE PROCEDURE WAS COMPLETED. KNOT ADVANCEMENT WAS SUCCESSFUL WITH THE SUTURE OF THE FIRST PROGLIDE DEVICE. WHILE POST CLOSING WITH THE SUTURE OF THE SECOND PROGLIDE DEVICE, THE SUTURE (INCLUDING THE KNOT) AND A NEEDLE TIP CAME OUT WITH THE SUTURE TRIMMER WHEN RETRACTED. NO TISSUE DAMAGE WAS NOTED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. 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
    1350008 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 14F SHEATH.| HEPARIN.| VESSEL CLOSURE: PROGLIDE.