BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 19047287 · Received April 4, 2024

    Report

    Report Number
    2024168-2024-04300
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 15, 2024
    Report Date
    June 21, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. D4: A PARTIAL UDI PROVIDED AS LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED ANALYSIS. THE REPORTED DETACHMENT WAS CONFIRMED. LOT HISTORY RECORD (LHR) 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 IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY. FACTORS THAT MAY CONTRIBUTE TO SHEATH BREAK INCLUDE, BUT NOT LIMITED TO, AGGRESSIVE MANIPULATION DURING INSERTION, PATIENT FEMORAL VESSEL/ANATOMY VARIABLES. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 CORRECTION: LOT NUMBER UPDATED FROM UNKNOWN TO 3101741

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE PRIOR TO A PATENT FORAMEN OVALE CLOSURE PROCEDURE. REPORTEDLY, WHEN RETRACTING THE PROSTYLE DEVICE OUT OF THE PATIENT, THE DEVICE BROKE WHERE THE DISTAL GUIDE MEETS THE PROXIMAL GUIDE LEAVING THE DISTAL GUIDE IN THE PATIENT. THE GUIDE WIRE EXIT PORT WAS STILL ACCESSIBLE SO, THE PHYSICIAN INSERTED A GUIDE WIRE TO MAINTAIN ACCESS AND PULLED OUT THE DISTAL GUIDE. THE SUTURE OF THE SAME PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A LARGE BORE AND THE PROCEDURE WAS COMPLETED. 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
    2340771 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3101741 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown