BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18768835 · Received February 23, 2024

    Report

    Report Number
    2024168-2024-02328
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    January 12, 2024
    Report Date
    February 29, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    28717648013083
    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

    B3: THE DATE OF EVENT IS ESTIMATED. 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 NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. TWO STERILE/UNUSED DEVICES WITH LOT # 3101542 AND 3102341 WERE RETURNED AND WERE SUCCESSFULLY TESTED WITH NO ANOMALIES NOTED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED USING A PROGLIDE DEVICE RELATIVE TO AN INTERVENTIONAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. REPORTEDLY, AT THE TIME OF DEPLOYMENT, THE FOOTPLATE WAS DIFFICULT TO CLOSE. AFTER DEPLOYMENT, THE SUTURE FRAYED AND BROKE DURING KNOT ADVANCEMENT. A NEW PROGLIDE DEVICE 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
    128971 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3102341 28717648013083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention