BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 17633025 · Received August 28, 2023

    Report

    Report Number
    2024168-2023-09357
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 6, 2023
    Report Date
    November 2, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE UNSPECIFIED ISSUE COULD NOT BE CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED FOR ANALYSIS. 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 WAS NOT PERFORMED AS A SIMILARITY COULD NOT BE DETERMINED. WITHOUT THE SPECIFIED FAILURE MODE, A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. THE ADDITIONAL PROSTYLE DEVICES MENTIONED IN B5 ARE FILED UNDER SEPARATE MFR REPORT NUMBERSD4 - LOT NUMBER UPDATED FROM UNKNOWN TO 3042542. D9, H3 - DEVICE RETURNING UPDATE FROM NI TO RETURNED. E1 - INITIAL REPORTER - PHYSICIAN UPDATED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3: ESTIMATED DATE OF EVENT: NA.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED AS A GENERAL COMMENT THAT THERE WERE FAILURES WITH FIVE PROSTYLE DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED AS A GENERAL COMMENT THAT THERE WERE FAILURES WITH PROSTYLE DEVICES. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459832 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3042542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention