BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21140735 · Received January 13, 2025

    Report

    Report Number
    2024168-2025-00506
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 20, 2024
    Report Date
    April 23, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL TESTING, DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE DIFFICULT TO REMOVE CANNOT BE CONFIRMED AS THE ISSUE IS CASE CONDITIONS RELATED AND CANNOT BE REPLICATED IN A LAB ENVIRONMENT. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THE FOOT CAUGHT VESSEL TISSUE DURING CLOSE AND WAS RELEASE USING THE RECOMMENDED PROCEDURE. THE RETURNED ANALYSIS WAS INCONCLUSIVE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTIONS: A2 ¿ DOB: UPDATED FROM NI TO (B)(6) 1962. A3A ¿ SEX: UPDATED FROM NI TO MALE. A4 ¿ WEIGHT, WEIGHT UNITS (PATIENT): UPDATED FROM NI TO 199 LBS. A5 ¿ ETHNICITY: UPDATED FROM NI TO NOT HISPANIC/LATINO. A6 ¿ RACE: UPDATED FROM NI TO BLACK OR AFRICAN AMERICAN. D4 - LOT #: UPDATED FROM UNKNOWN TO 4021441. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H6 - HEALTH EFFECT - IMPACT CODE: CODE 4624 WAS REMOVED. H6 - MEDICAL DEVICE PROBLEM CODE: CODE 1212 WAS REMOVED AND CODE 1528 WAS ADDED.

    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

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THIS WAS A VENOTOMY CLOSURE OF A RIGHT COMMON FEMORAL VEIN USING A PROSTYLE DEVICE AFTER AN INTERVENTIONAL PULMONARY VEIN ISOLATION PROCEDURE WITH AN 8FR SHEATH. THE DEVICE WAS ABLE TO BE REMOVED WITH NO ISSUES AFTER ANOTHER PHYSICIAN INSERTED THE PROSTYLE DEVICE A LITTLE FURTHER AND THEN ATTEMPTED THE REMOVAL USING THE NORMAL TECHNIQUE. A NEW PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE AFTER AN UNKNOWN PROCEDURE. REPORTEDLY, THE DEVICE GOT STUCK AND A VASCULAR SURGEON WAS CALLED. A NEW 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
    657449 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4021441 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention