BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 16973957 · Received May 22, 2023

    Report

    Report Number
    2024168-2023-05404
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    April 30, 2023
    Report Date
    June 29, 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
    JA
    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. E1 - FACILITY NAME: (B)(6) HOSPITAL.

    Additional Manufacturer Narrative · 0

    E1 - FACILITY NAME: DEPARTMENT OF NEUROSURGERY, OKINAWA TOKUSHUKAI CHUBU TOKUSHUKAI HOSPITAL THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. FACTORS THAT MAY CONTRIBUTE TO A DEVICE ENTRAPMENT INCLUDE BUT ARE NOT LIMITED TO; TISSUE OR SUTURE CAUGHT IN THE FOOT, OR POSTERIOR CUFF PARTLY DEPLOYED IN THE FOOT. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER A THROMBOSIS REMOVAL PROCEDURE IN CEREBRAL ARTERY USING AN 8F SHEATH. REPORTEDLY, AFTER THE FOOT CLOSED, THE DEVICE WAS REPEATEDLY PUSHED DOWN AND PULLED BACK TO BE REMOVED. THE PROSTYLE DEVICE WAS UNABLE TO BE REMOVED. THE DEVICE WAS REMOVED VIA SURGICAL INCISION OF THE ACCESS SITE. HEMOSTASIS WAS ACHIEVED WITH DIRECT SUTURING OF THE VESSEL. THERE WAS A 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
    761397 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12773-03 2121141 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention