BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 10111667 · Received June 2, 2020

    Report

    Report Number
    2024168-2020-04677
    Event Type
    Injury
    Date Received
    June 2, 2020
    Date of Event
    May 6, 2020
    Report Date
    July 28, 2020
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA AND TO CAPTURE STERILE DEVICE TESTING. STERILE DEVICES FROM THE ACCOUNT WITH THE SAME LOT NUMBER AS THE ORIGINAL COMPLAINT DEVICE WERE TESTED FOR NEEDLE TO CUFF MISS/ SUTURE RETRIEVAL ISSUES AND ALL UNITS PASSED SUCCESSFULLY. ATTACHMENT: HANDWRITTEN MEDWATCH LINKED TO MW 5095020NA - ATTACHMENT: [CN-033156 MEDWATCH.PDF].

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED ¿NO SUTURE PRESENT WHEN THE PROGLIDE PLUNGER WAS REMOVED¿ WAS NOT CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ATTACHMENT: USER FACILITY MEDWATCH REATTACHED.NA - ATTACHMENT: [CN-033156 MEDWATCH.PDF].

    Description of Event or Problem · 0

    SUBSEQUENT TO FILING THE INITIAL REPORT, AN EMAIL WAS RECEIVED FROM THE FDA COMMUNICATING THAT THE ATTACHED MEDWATCH FORM ON THE INITIAL REPORT WAS UNABLE TO BE OPENED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED WITH A FURTHER COPY OF THE MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER AN INTERVENTIONAL ATRIAL FIBRILLATION ELECTROPHYSIOLOGY PROCEDURE. REPORTEDLY, NO SUTURE WAS PRESENT WHEN THE PROGLIDE PLUNGER WAS REMOVED. ANOTHER PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. VOLUNTARY MEDWATCH REPORT RECEIVED WHICH STATES: "PERCLOSE FAILED TO DEPLOY SUTURE. WIRE INSERTED AND PERCLOSE REPLACED WITH NEW PERCLOSE." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577041 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 0012041 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATH: 6F, HEPARIN