BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18361056 · Received December 19, 2023

    Report

    Report Number
    2024168-2023-14255
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 29, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE BREAK WAS OBSERVED AS A LINK BREAK. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, LINK 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: LOT NUMBER UPDATED FROM 3070442 TO 3050841.

    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

    THIS WAS REPORTED AS AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN INTERVENTIONAL ON-TABLE ANGIOGRAM PROCEDURE. REPORTEDLY, THERE WAS NO SUTURE SEEN ON PLUNGER WITHDRAWAL. UPON INSPECTION OF THE DEVICE, IT WAS NOTED THAT THE KNOT WAS FORMED; HOWEVER, A SUTURE SEPARATION HAD OCCURRED. THE SUTURE OF A NEW PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE ON-TABLE ANGIOGRAM PROCEDURE WAS COMPLETED USING THE SAME 6F SIZED SHEATH. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURE. THERE WAS NO REPORTED 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
    1953767 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3050841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention