BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18142542 · Received November 15, 2023

    Report

    Report Number
    2024168-2023-12704
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 25, 2023
    Report Date
    December 29, 2023
    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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD 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 OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. D4: LOT NUMBER CHANGED FROM 3071443 TO 3081841.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ESTIMATED. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF AN UNKNOWN VESSEL USING A PROGLIDE AFTER A ELECTROPHYSIOLOGY ABLATION INTERVENTIONAL PROCEDURE. REPORTEDLY A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED. ANOTHER PROGLIDE WAS USED BUT THE SAME OCCURRED. ANOTHER PROGLIDE WAS USED BUT THE PLUNGER WAS UNABLE TO BE DEPRESSED. ANOTHER PROGLIDE 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
    293188 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3081841 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention