BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18030676 · Received October 30, 2023

    Report

    Report Number
    2024168-2023-11958
    Event Type
    Injury
    Date Received
    October 30, 2023
    Date of Event
    August 16, 2023
    Report Date
    January 18, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THERE WAS NO IDENTIFIED MAL FUNCTION, NOT AN INDICATION OF MAL FUNCTION IN THE RETURNED DEVICE. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. THE ROOT CAUSE OF THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THE SUBSEQUENT TREATMENTS ARE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, BASED ON THE INFORMATION PROVIDED IT IS POSSIBLE A CUFF MISS OCCURRED. THE COMPRESSIVE DAMAGE IS TYPICAL OF DEVICE USE. ADDITIONALLY, THE PLUNGER AND SUTURE WERE NOT RETURNED TO COMPLETE A FULL ANALYSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D4: LOT NUMBER UPDATED FROM 2092141 TO 2112942.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE USING FOUR PROGLIDE DEVICES RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING THE IMPLANTATION, THE SUTURE OF ONE OF THE FOUR PROGLIDE DEVICES DID NOT WORK. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. 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
    215880 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2112942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention