BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 21044799 · Received December 30, 2024

    Report

    Report Number
    2024168-2024-15418
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    April 25, 2024
    Report Date
    March 17, 2025
    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 NEEDLE TO CUFF MISS WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTY 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4- PART #/ LOT # WERE UPDATED FROM 12773-02/3070241 TO 12673-05/3072041.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT A VESSEL CLOSURE WAS ATTEMPTED WITH A PROSTYLE DEVICE AFTER A PROCEDURE. REPORTEDLY, THE THREADS [SUTURE KNOT] WAS FOUND LOOSE UPON PLUNGER REMOVAL, THEREFORE THE DEVICE COULD NOT BE USED FOR CLOSURE. THE METHOD OF HEMOSTASIS WAS NOT PROVIDED. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS A PROGLIDE (NOT PROSTYLE). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VESSEL CLOSURE WAS ATTEMPTED WITH A PROSTYLE DEVICE AFTER A PROCEDURE. REPORTEDLY, THE THREADS [SUTURE KNOT] WAS FOUND LOOSE UPON PLUNGER REMOVAL, THEREFORE THE DEVICE COULD NOT BE USED FOR CLOSURE. THE METHOD OF HEMOSTASIS WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253663 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3072041 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention