BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18608762 · Received January 30, 2024

    Report

    Report Number
    2024168-2024-01219
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    December 19, 2023
    Report Date
    March 20, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 DIFFICULT TO ADVANCE COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. HOWEVER, A PROXY 0.038INCH GUIDE WIRE AND WAS BACKLOADED SUCCESSFULLY. 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 IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. FACTORS THAT CONTRIBUTE TO DIFFICULT TO ADVANCE THE GUIDE WIRE, INCLUDE, BUT NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS (OCCLUSION OF THE SHEATH DUE TO EXCESSIVE BLOOD CLOT OR OTHER BIOLOGICAL MATTERS; PATIENT ARTERY ANATOMY VARIABLES). 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. D4 - LOT NUMBER UPDATED FROM 3080141 TO 3070641 D4: EXPIRATION DATE AND H4: MANUFACTURING DATE CORRECTED AS A RESULT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE USING A PROSTYLE DEVICE. REPORTEDLY, THE LUMEN OF THE PROSTYLE WAS NOT OPEN FOR THE WIRE TO PASS THROUGH [THE DEVICE WAS UNABLE TO BE ADVANCED ONTO THE GUIDE WIRE]. A NEW PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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
    1141700 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3070641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention