BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 19594527 · Received June 24, 2024

    Report

    Report Number
    2024168-2024-07511
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. ADDITIONALLY, FOUR STERILE/UNUSED DEVICES WITH LOT # 3112341 WERE RETURNED AND WERE SUCCESSFULLY TESTED WITH NO ANOMALIES NOTED. AS SUCH, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. FACTORS THAT CONTRIBUTE TO THE INABILITY TO RETRACT THE LEVER/OPEN FOOT, INCLUDE, BUT NOT LIMITED TO TISSUE, CALCIFICATION OR SUTURE CAUGHT IN FOOT. FACTORS THAT MAY CONTRIBUTE TO OBSTRUCTION OF FLOW INCLUDE, BUT NOT LIMITED TO UNDER INSERTION OR IMPROPER INSERTION ANGLE, THE MARKER PORT NOT BEING IN THE ARTERIAL LUMEN. THE TREATMENT APPEARS TO BE RELATED TO 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. ADDITIONAL INFORMATION: D4 - MODEL # ADDED CORRECTIONS: D1 - BRAND NAME UPDATED D2A - COMMON DEVICE NAME UPDATED D3 - NAME UPDATED D3 - ADDRESS, CITY, POSTAL CODE UPDATED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING A PROGLIDE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THERE WAS NO PULSATILE FLOW COMING FROM THE MARKER LUMEN. ADDITIONALLY, WHEN THE FOOTPLATE WAS ATTEMPTED TO BE OPENED VIA THE LEVER, THERE WAS EXTREME DIFFICULTY OPENING THE LEVER. THE FOOTPLATE LEVER WAS CLOSED AND THE DEVICE WAS REMOVED. MANUAL COMPRESSION 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
    2167897 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 3112341 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention