BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18271797 · Received December 5, 2023

    Report

    Report Number
    2024168-2023-13515
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 15, 2023
    Report Date
    March 5, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY TO OPEN THE LEVER WAS NOT CONFIRMED. THE REPORTED IRREGULAR APPEARANCE COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. A NEEDLE TO CUFF MISS WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO THE 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. D4 - LOT # UPDATED FROM 3082241 TO 3052841.

    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 THIS WAS A VENOUS CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING A PROSTYLE DEVICE AFTER AN ATRIAL FIBRILLATION PROCEDURE WITH AN 8F SHEATH. REPORTEDLY, BLOOD FLOW WAS NOTED THROUGH THE MARKER LUMEN. AS THE FOOTPLATE LEVER WAS OPENED IT WAS NOTICED THE LINK WAS NOT IN THE CORRECT PLACE. IT WAS STOPPING THE FOOTPLATE LEVER FROM OPENING. THE DEVICE WAS REMOVED. ANOTHER PROSTYLE 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
    2159261 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3052841 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention