BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 19784214 · Received July 19, 2024

    Report

    Report Number
    2024168-2024-08571
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULT TO ADVANCE THE GUIDE WIRE WAS CONFIRMED. A REVIEW OF THE PRODUCTION RECORDS AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) DATABASE 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 REPORTED DIFFICULT TO ADVANCE THE GUIDE WIRE WAS CONCLUDED TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE DUE TO THE OBSERVED OUT OF POSITION OF THE SINGLE LUMEN INSIDE THE SHEATH. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. D4 CORRECTION: LOT NUMBER UPDATED FROM 4051341 TO 4031141.

    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 AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WITH A PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 7FR SHEATH HOLE PRIOR TO AN INTERVENTIONAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, A PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. WHILE PLACING THE NEXT PROSTYLE DEVICE, THE 0.038" GUIDEWIRE BECAME STUCK AT THE GUIDE/FOOT AREA JUST AFTER EXITING THE GUIDE WIRE EXIT PORT OF THE DEVICE. THE SUTURE OF A NEW PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A LARGE-BORE HOLE SHEATH AND THE TAVI PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. 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
    1753725 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4031141 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention