BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 17190566 · Received June 23, 2023

    Report

    Report Number
    2024168-2023-06657
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    April 19, 2023
    Report Date
    August 10, 2023
    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
    NJ, 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

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED CUFF MISS COULD NOT BE TESTED DUE TO DEVICE COMPONENTS NOT BEING RETURNED. THE FOOT DEPLOYMENT AND RETRACTION WERE VERIFIED VIA MANUALLY OPENING AND CLOSING THE LEVER WITH NO DIFFICULTY NOTED. A REVIEW OF THE LOT HISTORY RECORD 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 PATIENT EFFECT OF TISSUE INJURY IS LISTED IN THE PROSTYLE INSTRUCTIONS FOR USE (IFU), AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH USE OF THE SUTURE MEDIATED CLOSURE DEVICES. THE REPORTED DIFFICULTIES 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.D4, H3; LOT NUMBER UPDATED FROM 2120842 TO 3012741.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED AFTER AN INTERVENTIONAL LEG ANGIOGRAM PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE SUTURE WAS NOT PRESENT WHEN THE PLUNGER WAS REMOVED. UPON RETRIEVAL, TISSUE WAS FOUND AT THE END OF THE DEVICE AND VESSEL DAMAGE WAS NOTED. MANUAL COMPRESSION WAS HELD TEMPORARILY UNTIL A NON-ABBOTT SUTURE BECAME AVAILABLE TO TREAT THE VESSEL DAMAGE AND ACHIEVE HEMOSTASIS. THERE WAS 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
    855564 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12773-03 3012741 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention