BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 14621883 · Received June 7, 2022

    Report

    Report Number
    2024168-2022-06047
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 18, 2022
    Report Date
    August 9, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 REPORTED CUFF MISS WAS NOT CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE PROGLIDE DEVICE WAS USED IN THE ANTERIOR TIBIAL ARTERY. IT SHOULD BE NOTED THAT THE ELECTRONIC PROGLIDE INSTRUCTIONS FOR USE (IFU), STATES: THE PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY AND VEIN ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED DIFFICULTIES. 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 - LOT NO UPDATED FROM 1062641 TO 1030242. D4 - EXPIRATION DATE UPDATED FROM 4/30/2023 TO 1/31/2023 H4 - DEVICE MFG DATE UPDATED FROM 6/26/2021 TO 3/2/2021

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT ANTERIOR TIBIAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INTERVENTIONAL PROCEDURE USING A 8F SHEATH. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED. MANUAL COMPRESSION 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
    1141305 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 1030242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention