BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 20181269 · Received September 10, 2024

    Report

    Report Number
    2024168-2024-10604
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    July 30, 2024
    Report Date
    November 15, 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

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE SEPARATION WAS NOT CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED. THE POSTERIOR FOOT WAS SEPARATED AND NOT RETURNED. THE FOOT SEPARATION WAS NOT REPORTED AND LIKELY OCCURRED DURING POST PROCEDURE HANDLING, HOWEVER, THIS COULD NOT BE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, LINK/SUTURE PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. D4 CORRECTION: LOT # UPDATED FROM 4013142 TO 3110741.

    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.

    Description of Event or Problem · 0

    A POSTERIOR FOOT BREAK NOT RETURNED WAS FOUND DURING EVALUATION OF THE RETURNED DEVICE. THE LOCATION OF THE DETACHED FOOT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE USING TWO PROGLIDE DEVICES RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING USE OF THE DEVICES, THE THREAD [SUTURE] BROKE. 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
    222608 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3110741 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention