BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 13581248 · Received February 22, 2022

    Report

    Report Number
    2024168-2022-01872
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    February 2, 2022
    Report Date
    April 11, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 DIFFICULTY TRACKING THE PROGLIDE DEVICE OVER THE GUIDE WIRE WAS NOT CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. FEMORAL IMAGING WAS NOT PERFORMED. IT SHOULD BE NOTED THAT THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (EIFU) 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. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D4: LOT NUMBER WAS CHANGED FROM 1091341 TO 1100441 EXPIRATION DATE WAS CHANGED FROM 07/31/2023 TO 08/31/2023. DEVICE MFG DATE WAS CHANGED FROM 09/13/2021 TO 10/04/2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VENOUS CLOSURE OF THE RIGHT COMMON FEMORAL VEIN WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN ELECTROPHYSIOLOGY ABLATION INTERVENTIONAL PROCEDURE USING A 7F HOLE. REPORTEDLY, THE PROGLIDE DEVICE COULD NOT TRACK OVER A 0.035 INCH GUIDEWIRE AND THE DEVICE WOULD NOT FULLY ADVANCE INTO THE ACCESS SITE. ONLY THE FRONT SECTION OF THE PROGLIDE DEVICE WAS INSIDE OF THE ANATOMY. ANOTHER PROGLIDE WAS USED WITH THE SAME WIRE 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
    632284 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 1100441

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention