BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 20181839 · Received September 10, 2024

    Report

    Report Number
    2024168-2024-10610
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    July 12, 2024
    Report Date
    October 31, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    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

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED POUCH. HE UNSPECIFIED FAILURE MODE COULD NOT BE TESTED AS SOME COMPONENTS WERE NOT RETURNED. REVIEW OF THE PRODUCTION RECORDS AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE NOT PERFORMED BECAUSE A SPECIFIC FAILURE MODE FOR THIS COMPLAINT WAS NOT PROVIDED. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY WAS NOT PERFORMED AS A SIMILARITY COULD NOT BE DETERMINED. WITHOUT THE SPECIFIED FAILURE MODE A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER THE TREATMENT APPEARS TO BE RELATED 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 NUMBER UPDATED FROM 4013142 TO 3110741.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE USING TWO PROGLIDE DEVICES RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, AN UNSPECIFIED FAILURE OCCURRED WITH THE TWO PROGLIDE DEVICES. 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
    2294964 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3110741 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention