BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 11423506 · Received March 5, 2021

    Report

    Report Number
    2024168-2021-01751
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    February 15, 2021
    Report Date
    April 23, 2021
    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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE DETACHMENT WAS NOT CONFIRMED AS THE SUTURE WAS NOT RETURNED FOR ANALYSIS. REPORTEDLY, FEMORAL IMAGING WAS NOT PERFORMED. IT SHOULD BE NOTED THAT THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATES: PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED DIFFICULTIES. A REVIEW OF THE MANUFACTURING RECORDS 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, OR TENSIONING ANGLE IS NOT BEING COAXIAL 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. D4: THE LOT NUMBER HAS BEEN CORRECTED FROM 0120741 TO 0111241.

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL PROGLIDE DEVICE IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. (B)(4). PER INSTRUCTIONS FOR USE: UNDER WARNINGS - PERFORM A FEMORAL ANGIOGRAM/IMAGING TO VERIFY THE LOCATION OF THE PUNCTURE SITE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH TWO PROGLIDE DEVICES WAS ATTEMPTED IN THE LEFT FEMORAL VEIN VIA A 5FR SHEATH USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN ABLATION PROCEDURE. THE SUTURES WERE SUCCESSFULLY PLACED. THE SHEATH WAS UPSIZED TO 15FR AND THE ABLATION PROCEDURE WAS COMPLETED. REPORTEDLY, WHEN ADVANCING THE SUTURE TRIMMER TO TRIM THE SUTURES, THE SUTURE BROKE AND PULLED OUT OF THE VEIN WITH BOTH PROGLIDE DEVICES. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. FEMORAL IMAGING WAS NOT PERFORMED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318760 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 0111241 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 5FR, HEPARIN| SHEATH: 5FR, HEPARIN