BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 19097360 · Received April 12, 2024

    Report

    Report Number
    2024168-2024-04618
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 27, 2024
    Report Date
    June 19, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648113154
    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

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE UNSPECIFIED FAILURE WAS OBSERVED AS A NEEDLE TO CUFF MISS. LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE NEEDLE TO CUFF MISS 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 REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 CORRECTION - LOT # WAS UPDATED FROM 3061941 TO 2101541.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ESTIMATED AS (B)(6) 2024. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    THIS WAS REPORTED AS A CLOSURE USING A PROGLIDE DEVICE. REPORTEDLY, AN UNSPECIFIED FAILURE OCCURRED. THE METHOD OF HEMOSTASIS WAS NOT PROVIDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793965 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2101541 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention